- Pasha Food Distribution USA, Inc.,of Chatsworth, California did not have a FSVP for roasted eggplant product, dried sumac and tahini products. The company also did not register the facility as required.
- Kaymile Trading, Inc.of South El Monte, California did not develop, maintain, and follow an FSVP fir the following items - Roasted onion granules and coarse black pepper
- Ventura Terra Garden Inc., of Ventura, CA was not in compliance for fresh packaged enoki mushrooms.
FDA WARNING LETTERS
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pasha-food-distribution-usa-inc-607108-05182020Pasha Food Distribution USA, Inc.
MARCS-CMS 607108 — May 18, 2020
Recipient:
Mohammed Musalam
President
Pasha Food Distribution USA, Inc.
18375 Ventura Blvd, #247
Tarzana, CA 91356-4218
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
May 18, 2020
Re: CMS # 607108
Dear Mr. Musalam:
On March 18, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Pasha Food Distribution USA, Inc., located at 9813 Independence Avenue, Chatsworth, California 91311-4320. We also conducted an inspection on September 12, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 384a] and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the roasted eggplant product you import from (b)(4), and dried sumac and tahini products manufactured by (b)(4). You did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection and the follow-up inspection on March 18, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your email response dated March 30, 2020. In your email, you declared you are a very small importer with sales less than $(b)(4) per year. However, we could not evaluate this response because you did not provide supporting documentation that you meet the definition of a very small importer (see 21 CFR 1.500 for the definition of very small importer). Furthermore, even if you meet the definition of very small importer, you are still required to follow FSVP requirements. If you choose to comply with the requirements for very small importers, you must document that you meet the definition of very small importer in 21 CFR 1.500 before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year (21 CFR 1.512(b)(1)(i)(A)). In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act (21 CFR 1.512(b)(3)(i)). We could not evaluate whether you are in compliance with these supplier verification requirements for very small importers because, while your response includes letters from your (b)(4) suppliers, these letters do not address the suppliers’ compliance with the relevant food safety standards and you did not explain how the letters apply to your compliance with the requirements of the FSVP regulation. The letter from (b)(4) states that the establishment “has FDA Registration” and has been producing certain products. The letter from (b)(4) states that the establishment is a “registered production facility” with FDA and “our company is producing food products like Tahini ad Sumac in compliance with USA FDA Regulations.”
Your significant violations of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop an FSVP for roasted eggplant manufactured by (b)(4), and dried sumac and tahini manufactured by (b)(4).
If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).
Failure to Register Food Facility:
In addition, FDA has determined that your facility at 9813 Independence Avenue, Chatsworth, California 91311-4320 is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the inspection, you were advised of this requirement. Our records indicate that you did not register your facility as required. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [U.S.C. § 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act [21 U.S.C. 381(a)(3)] to refuse admission of roasted eggplant imported from (b)(4) and dried sumac and tahini imported from (b)(4). We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act [21 U.S.C. 331(zz)].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation.) If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: James R. Ahlrep, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact James Ahlrep via email at james.ahlrep@fda.hhs.gov. Please reference CMS # 607108 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kaymile-trading-inc-608153-07282020
Kaymile Trading, Inc.
MARCS-CMS 608153 — July 28, 2020
Recipient:
Nancy H. Zhang
CEO
Kaymile Trading, Inc.
2615 Loma Avenue
South El Monte, CA 91733-1419
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
July 28, 2020
Re: CMS # 608153
Dear Ms. Zhang:
On April 24, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Kaymile Trading, Inc., 2615 Loma Avenue, South El Monte, California 91733-1419. We also conducted an initial on-site FSVP inspection on September 6, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 384a] and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your roasted onion granules imported from (b)(4) and coarse black pepper imported from (b)(4), and roasted garlic granules imported from (b)(4). You did not have FSVPs for the roasted onion granules or coarse black pepper products.
While you provided a Hazard Analysis and Critical Control Point (HACCP) plan document for the roasted garlic granules, you did not meet the FSVP requirements for this product, as discussed in greater detail below. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on September 6, 2018, and the follow-up inspection on April 24, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to either Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop an FSVP for each of the following foods:
a. Roasted onion granules imported from (b)(4) located in (b)(4).
b. Coarse black pepper imported from (b)(4) located in (b)(4).
2. For the roasted garlic granules imported from (b)(4), located in (b)(4), you did not meet your requirements to conduct a hazard analysis in accordance with 21 CFR 1.504(a). During the inspection, you provided a copy of your foreign supplier’s HACCP plan. You may meet your requirement to conduct a hazard analysis, as required by 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of your supplier’s hazard analysis per 21 CFR 1.504(d). You did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d).
3. You must approve your foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). You did not document your approval of your foreign supplier of roasted garlic granules imported from (b)(4), as required by 21 CFR 1.505(b).
4. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 1.506(a)(1).
5. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import, as required by 21 CFR 1.506(b).
6. You did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e). For example, you did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for your foreign supplier (b)(4), before importing roasted garlic granules and periodically thereafter.
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct these violations, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act [21 U.S.C. 381(a)(3)] to refuse admission of roasted onion granules from your foreign supplier (b)(4), and roasted garlic granules and coarse black pepper from your foreign supplier (b)(4).
We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these products. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act [21 U.S.C. 331(zz)].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: James R. Ahlrep, Compliance Officer, Division of West Coast Imports, U.S. Food and Drug Administration, 19701 Fairchild, Irvine, California 92612-2506. If you have any questions regarding this letter, you may contact James Ahlrep via email at james.ahlrep@fda.hhs.gov. Please reference CMS #608153 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ventura-terra-garden-inc-608649-07292020
Ventura Terra Garden Inc.
MARCS-CMS 608649 — July 29, 2020
Recipient:
Xianmin Guan
President
Ventura Terra Garden Inc.
4440 Olivas Park Drive #A
Ventura, CA 93001-4310
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
July 29, 2020
Re: CMS # 608649
Dear Mr. Guan:
On April 15-17, 20-21 and 29, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm, Ventura Terra Garden Inc., 4440 Olivas Park Drive #A, Ventura, CA 93001. This remote inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
The inspection was initiated due to enoki mushrooms from (b)(4) being associated with a Listeria monocytogenes outbreak. Ms. Yip, your food safety manager, provided a copy of a voluntary recall press release by Forest Mushroom Food Inc., dba Guan’s Mushroom Co., dated March 23, 2020. The press release stated that Forest Mushroom was recalling "all cases of its 200g/7.05 ounce packages of Enoki Mushroom (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes…" Ms. Yip stated that your firm imports mushrooms (b)(4). In addition, FDA collected three (3) samples of enoki mushrooms (b)(4) and that analysis revealed the presence of Listeria monocytogenes.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your fresh packaged enoki mushrooms imported from your foreign supplier (b)(4). You did not have an FSVP for this product. Additionally, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the documents you presented as your FSVPs for your enoki mushrooms. Because of this significant violation, your firm is not in compliance with section 805 of the FD&C Act.
At the conclusion of the FSVP inspection, our investigator emailed you a copy of Form FDA 483a, FSVP Observations.
We have not received your response to Form FDA 483a. We acknowledge receipt of your email response dated May 21, 2020 wherein you indicated that your "company is working on the hazard analysis and revising the SOPs for approved foreign suppliers. However, we need more time to complete the corrective actions and it is expected to complete by end of May." As of the date of this letter, we have not received a response and therefore, we are unable to evaluate the adequacy of your response.
Your significant violations of the FSVP regulation are as follows:
1. You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control in accordance with 21 CFR 1.504(a). You may rely on the hazard analysis of your foreign supplier to meet your obligations under the FSVP regulation, however, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazards analysis as required per 21 CFR 1.504(d). You may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis required by 21 CFR 1.504(d).
2. An onsite audit of your foreign supplier, (b)(4), did not consider an applicable food safety regulation, in accordance with 21 CFR 1.506(e)(1)(i)(B). Specifically, your third-party "Audit Checklist Report" (b)(4) dated April 4, 2019, for your enoki mushrooms imported from (b)(4)., did not include the Food Safety Modernization Act (FSMA) Produce Safety Rule as part of the criteria.
3. You did not promptly document your review and assessment of the results of a verification activity that was conducted by another entity in accordance with 21 CFR 1.506(e)(3). Specifically, you did not have documentation that you reviewed and assessed the result of third-party (b)(4) audit for your Enoki mushroom imported from, (b)(4).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of enoki mushrooms, imported from your foreign supplier (b)(4).
We may place the food from the identified foreign supplier on detention without physical examination (DWPE) when you import these products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Actor the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Ms. Jung-Lau via email at Juliane.Jung-Lau@fda.hhs.gov. Please reference CMS # 608649 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
cc:
Division of West Coast Imports
United States
WARNING LETTER
May 18, 2020
Re: CMS # 607108
Dear Mr. Musalam:
On March 18, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Pasha Food Distribution USA, Inc., located at 9813 Independence Avenue, Chatsworth, California 91311-4320. We also conducted an inspection on September 12, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 384a] and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the roasted eggplant product you import from (b)(4), and dried sumac and tahini products manufactured by (b)(4). You did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection and the follow-up inspection on March 18, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your email response dated March 30, 2020. In your email, you declared you are a very small importer with sales less than $(b)(4) per year. However, we could not evaluate this response because you did not provide supporting documentation that you meet the definition of a very small importer (see 21 CFR 1.500 for the definition of very small importer). Furthermore, even if you meet the definition of very small importer, you are still required to follow FSVP requirements. If you choose to comply with the requirements for very small importers, you must document that you meet the definition of very small importer in 21 CFR 1.500 before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year (21 CFR 1.512(b)(1)(i)(A)). In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act (21 CFR 1.512(b)(3)(i)). We could not evaluate whether you are in compliance with these supplier verification requirements for very small importers because, while your response includes letters from your (b)(4) suppliers, these letters do not address the suppliers’ compliance with the relevant food safety standards and you did not explain how the letters apply to your compliance with the requirements of the FSVP regulation. The letter from (b)(4) states that the establishment “has FDA Registration” and has been producing certain products. The letter from (b)(4) states that the establishment is a “registered production facility” with FDA and “our company is producing food products like Tahini ad Sumac in compliance with USA FDA Regulations.”
Your significant violations of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop an FSVP for roasted eggplant manufactured by (b)(4), and dried sumac and tahini manufactured by (b)(4).
If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).
Failure to Register Food Facility:
In addition, FDA has determined that your facility at 9813 Independence Avenue, Chatsworth, California 91311-4320 is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During the inspection, you were advised of this requirement. Our records indicate that you did not register your facility as required. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [U.S.C. § 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act [21 U.S.C. 381(a)(3)] to refuse admission of roasted eggplant imported from (b)(4) and dried sumac and tahini imported from (b)(4). We may place the foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act [21 U.S.C. 331(zz)].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation.) If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: James R. Ahlrep, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact James Ahlrep via email at james.ahlrep@fda.hhs.gov. Please reference CMS # 607108 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kaymile-trading-inc-608153-07282020
Kaymile Trading, Inc.
MARCS-CMS 608153 — July 28, 2020
Recipient:
Nancy H. Zhang
CEO
Kaymile Trading, Inc.
2615 Loma Avenue
South El Monte, CA 91733-1419
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
July 28, 2020
Re: CMS # 608153
Dear Ms. Zhang:
On April 24, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Kaymile Trading, Inc., 2615 Loma Avenue, South El Monte, California 91733-1419. We also conducted an initial on-site FSVP inspection on September 6, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 384a] and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your roasted onion granules imported from (b)(4) and coarse black pepper imported from (b)(4), and roasted garlic granules imported from (b)(4). You did not have FSVPs for the roasted onion granules or coarse black pepper products.
While you provided a Hazard Analysis and Critical Control Point (HACCP) plan document for the roasted garlic granules, you did not meet the FSVP requirements for this product, as discussed in greater detail below. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on September 6, 2018, and the follow-up inspection on April 24, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to either Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, your firm did not develop an FSVP for each of the following foods:
a. Roasted onion granules imported from (b)(4) located in (b)(4).
b. Coarse black pepper imported from (b)(4) located in (b)(4).
2. For the roasted garlic granules imported from (b)(4), located in (b)(4), you did not meet your requirements to conduct a hazard analysis in accordance with 21 CFR 1.504(a). During the inspection, you provided a copy of your foreign supplier’s HACCP plan. You may meet your requirement to conduct a hazard analysis, as required by 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of your supplier’s hazard analysis per 21 CFR 1.504(d). You did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d).
3. You must approve your foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). You did not document your approval of your foreign supplier of roasted garlic granules imported from (b)(4), as required by 21 CFR 1.505(b).
4. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 1.506(a)(1).
5. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import, as required by 21 CFR 1.506(b).
6. You did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e). For example, you did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for your foreign supplier (b)(4), before importing roasted garlic granules and periodically thereafter.
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct these violations, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act [21 U.S.C. 381(a)(3)] to refuse admission of roasted onion granules from your foreign supplier (b)(4), and roasted garlic granules and coarse black pepper from your foreign supplier (b)(4).
We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these products. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act [21 U.S.C. 331(zz)].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: James R. Ahlrep, Compliance Officer, Division of West Coast Imports, U.S. Food and Drug Administration, 19701 Fairchild, Irvine, California 92612-2506. If you have any questions regarding this letter, you may contact James Ahlrep via email at james.ahlrep@fda.hhs.gov. Please reference CMS #608153 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ventura-terra-garden-inc-608649-07292020
Ventura Terra Garden Inc.
MARCS-CMS 608649 — July 29, 2020
Recipient:
Xianmin Guan
President
Ventura Terra Garden Inc.
4440 Olivas Park Drive #A
Ventura, CA 93001-4310
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
July 29, 2020
Re: CMS # 608649
Dear Mr. Guan:
On April 15-17, 20-21 and 29, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm, Ventura Terra Garden Inc., 4440 Olivas Park Drive #A, Ventura, CA 93001. This remote inspection was conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
The inspection was initiated due to enoki mushrooms from (b)(4) being associated with a Listeria monocytogenes outbreak. Ms. Yip, your food safety manager, provided a copy of a voluntary recall press release by Forest Mushroom Food Inc., dba Guan’s Mushroom Co., dated March 23, 2020. The press release stated that Forest Mushroom was recalling "all cases of its 200g/7.05 ounce packages of Enoki Mushroom (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes…" Ms. Yip stated that your firm imports mushrooms (b)(4). In addition, FDA collected three (3) samples of enoki mushrooms (b)(4) and that analysis revealed the presence of Listeria monocytogenes.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your fresh packaged enoki mushrooms imported from your foreign supplier (b)(4). You did not have an FSVP for this product. Additionally, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the documents you presented as your FSVPs for your enoki mushrooms. Because of this significant violation, your firm is not in compliance with section 805 of the FD&C Act.
At the conclusion of the FSVP inspection, our investigator emailed you a copy of Form FDA 483a, FSVP Observations.
We have not received your response to Form FDA 483a. We acknowledge receipt of your email response dated May 21, 2020 wherein you indicated that your "company is working on the hazard analysis and revising the SOPs for approved foreign suppliers. However, we need more time to complete the corrective actions and it is expected to complete by end of May." As of the date of this letter, we have not received a response and therefore, we are unable to evaluate the adequacy of your response.
Your significant violations of the FSVP regulation are as follows:
1. You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control in accordance with 21 CFR 1.504(a). You may rely on the hazard analysis of your foreign supplier to meet your obligations under the FSVP regulation, however, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazards analysis as required per 21 CFR 1.504(d). You may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis required by 21 CFR 1.504(d).
2. An onsite audit of your foreign supplier, (b)(4), did not consider an applicable food safety regulation, in accordance with 21 CFR 1.506(e)(1)(i)(B). Specifically, your third-party "Audit Checklist Report" (b)(4) dated April 4, 2019, for your enoki mushrooms imported from (b)(4)., did not include the Food Safety Modernization Act (FSMA) Produce Safety Rule as part of the criteria.
3. You did not promptly document your review and assessment of the results of a verification activity that was conducted by another entity in accordance with 21 CFR 1.506(e)(3). Specifically, you did not have documentation that you reviewed and assessed the result of third-party (b)(4) audit for your Enoki mushroom imported from, (b)(4).
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of enoki mushrooms, imported from your foreign supplier (b)(4).
We may place the food from the identified foreign supplier on detention without physical examination (DWPE) when you import these products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Actor the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Ms. Jung-Lau via email at Juliane.Jung-Lau@fda.hhs.gov. Please reference CMS # 608649 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
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