FDA issued Warning Letters to three firms for not being in compliance with the FSVP regulations. These firms did not have FSVP in place for products they imported.
Global Commodities Corp., of Hayward, CA 94545 was not in compliance with the FSVP for Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves imported from (b)(4), Philippines; and Boy Bawang Mixed Nuts Snacks – Garlic imported from KSK Food Products, Philippines. The firm did not have FSVPs for these products.
H & C Food Inc., located at 1300 Metropolitan Ave, Brooklyn, NY was found not to be in compliance with the FSVP requirements for Enoki Mushroom imported from Green Co., Ltd, South Korea and Teriyaki Kimnori Roasted seaweed Snack (b)(4). The firm did not have FSVPs for these products.
Diamond Rock Food Imports, Inc.of Copiague, NY was not in compliance with the requirements of FSVP regulations for Tomato Sauce and Refried Red Beans products imported from (b)(4) and the Grape Soft Drink product imported from your (b)(4). The firm did not have an FSVP for these products or any other products imported by your firm.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-commodities-corp-607103-06032020
Global Commodities Corp.
MARCS-CMS 607103 — June 03, 2020
Recipient:
Mr. Ronald Yu & Mrs. Cathy C. Yu
Global Commodities Corp.
23759 Eichler Street, Suite G
Hayward, CA 94545-2783
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
June 3, 2020
Re: CMS # 607103
Dear Mr. Ronald Yu & Mrs. Cathy C. Yu:
On February 27, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at Global Commodities Corp., located at 23759 Eichler Street, Suite G, Hayward, CA 94545. We also conducted an initial inspection of September 12, 2017. These inspections were conducted to determine your firm’s 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 will 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 FSVPs for Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves imported from (b)(4), Philippines; and Boy Bawang Mixed Nuts Snacks – Garlic imported from KSK Food Products, Philippines. Your firm 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 on September 12, 2017 and the follow-up inspection on February 27, 2020, our investigator provided you in each instance a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response sent via email dated March 5, 2020 where you included documents from your foreign supplier, (b)(4), Philippines, such as a HACCP plan entitled “Bottled Tropical Fruit Preserves” dated May 10, 2019 (includes Sugar Palm Fruit and Macapuno String and others) and three SGS Certificates. You also included your document titled, “FSVP Foreign Supplier Verification Activity(ies) Worksheet Example” for “Macapuno Strings” and “Kaong” products. We are unable to evaluate the adequacy of your response because you did not provide details as to how the documents meet the requirements of the FSVP regulation. We address your response in more detail below.
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 Boy Bawang Mixed Nuts Snacks-Garlic manufactured by KSK Food Products, Philippines.
2. For a low-acid canned food not subject to further processing, you did not verify and document the food was produced accordance with the low-acid canned food regulations (part 113), or with respect to all matters not controlled by part 113, you did not have an FSVP, as required by 21 CFR 1.502(b)(1). Specifically, your firm did not document compliance with 21 CFR part 113 or otherwise develop an FSVP for Buenas Kaong Red Sugar Palm Fruit in syrup and Macapuno String in Syrup Preserves manufactured by (b)(4), Philippines.
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 the food products that you import including Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves manufactured by (b)(4) located in Philippines and Boy Bawang Mixed Nuts Snacks – Garlic manufactured by KSK Food Products located in Philippines. We may place the foods you import 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.
In addition to the above violations, we also have the following comments. In response to the Form FDA 483a, you provided FDA with a copy of your foreign supplier’s HACCP plan and SGS Certificates for Food Safety System Certification (ISO 22000), Good Manufacturing Practice (Codex Alimentarius), and HACCP Codex Alimentarius. To meet your obligation under the FSVP regulation, you did not provide FDA with evidence that you conducted a hazard analysis as required by 21 CFR 1.504(a). 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 (21 CFR 1.504(d)). You did not submit your supplier’s hazard analysis or your review and assessment of your supplier’s hazard analysis. Further, the FSVP regulation also generally requires that you evaluate your foreign supplier’s performance and document your approval, as required by 21 CFR 1.505; and conduct foreign supplier verification activities as required by 21 CFR 1.506, among other requirements. You did not provide FDA with evidence that you evaluated or approved your suppliers or conducted verification activities.
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: David Serrano, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Mr. Serrano via email at: david.serrano@fda.hhs.gov. Please reference CMS # 607103 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
Dan R. Solis
Program Division Director
Division of West Coast Imports
FDA WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/h-c-food-inc-607742-06222020
H & C Food Inc.
MARCS-CMS 607742 — June 22, 2020
Recipient:
Sai Lu Pan
Owner & CEO
H & C Food Inc.
1300 Metropolitan Ave.
Brooklyn, NY 11237
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 607742
Dear Ms. Sai Lu Pan:
On April 9, 2020 and April 14, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of H & C Food Inc., located at 1300 Metropolitan Ave, Brooklyn, NY 11237. We also conducted an initial on-site FSVP inspection on August 23, 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 Enoki Mushroom imported from Green Co., Ltd, South Korea and Teriyaki Kimnori Roasted seaweed Snack (b)(4). Your firm 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 most recent inspection on April 14, 2020 and the initial FSVP inspection on August 23, 2018, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your two emailed responses on May 4, 2020, one of which included attachments you describe as being from your “Korean fresh enoki mushroom supplier” and the other from your “Roasted Seaweed supplier (b)(4).” The four documents you associated with your Enoki Mushroom supplier are a Hazard Analysis Critical Control Point (HACCP) plan not translated to English, a Processing Risk Assessment that does not reference a product or company, and a Corrective Action plan and Staff Safety Risk Assessment that both list (b)(4), Green Co. Ltd.). The two documents you associated with your Teriyaki Kimnori Roasted seaweed Snack supplier are a HACCP plan for roasted products and copies of nutritional labeling for seasoned seaweed. We are unable to evaluate the adequacy of this response because you did not provide your review of these documents or how they would apply to your FSVP for these products. We also received your email on April 29, 2020, where you provided attachments related to your frozen rice balls and pears imported from (b)(4), which were not covered during our inspection.
Your significant violations of the FSVP regulation are as follows:
You did not meet your requirements to conduct a hazard analysis for your Enoki Mushroom imported from Green Co., Ltd., located in South Korea and your Teriyaki Kimnori Roasted seaweed Snack imported from (b)(4) in accordance with 21 CFR 1.504 because you did not evaluate your foreign suppliers’ performance in accordance with 21 CFR 1.505, nor did you perform foreign supplier verification activities in accordance with 21 CFR 1.506. Specifically, you did not document your review and assessment of your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d). The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements.
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 the Enoki Mushroom imported from Green Co. Ltd., South Korea, and Teriyaki Kimnori Roasted seaweed Snack imported (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.
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 revised 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). Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) david.trent-carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at david.trent-carlson@fda.hhs.gov. Please reference CMS # 607742 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/
Dawne Hines
Program Division Director
Division of Northeast Imports
FDA WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/diamond-rock-food-imports-inc-607128-06082020
Diamond Rock Food Imports Inc.
MARCS-CMS 607128 — June 08, 2020
Recipient:
Wesley E. Alvarado CEO
Diamond Rock Food Imports Inc.
1199 Sunrise Hwy Ste 2-3
Copiague, NY 11726
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 607128
June 8, 2020
Dear Mr. Wesley Alvarado:
On March 9, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at Diamond Rock Food Imports, Inc. located at 1199 Sunrise Hwy Ste 2-3 Copiague, NY. We also conducted an initial inspection on September 22, 2017. 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 Tomato Sauce and Refried Red Beans products you import from your (b)(4) the Grape Soft Drink product you import from your (b)(4). Your firm did not have an FSVP for these products or any other products imported by your firm. 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 9, 2020, our investigator provided you with a Form FDA 483a, FSVP Observations. We received your email dated April 2, 2020, stating that you intended to respond to our most recent Form 483a, but, to date, we have not received your response to either Form 483a.
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 the following foods:
• Tomato Sauce manufactured by (b)(4)
• Refried Red Beans manufactured by (b)(4)
• Grape Soft Drink manufactured by (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 the food products you import. We may place the foods you import 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.
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 revised 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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) slater.bartlett@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at slater.bartlett@fda.hhs.gov. Please reference CMS # 607128 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/
Dawne Hines
Program Division Director
Division of Northeast Imports
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-commodities-corp-607103-06032020
Global Commodities Corp.
MARCS-CMS 607103 — June 03, 2020
Recipient:
Mr. Ronald Yu & Mrs. Cathy C. Yu
Global Commodities Corp.
23759 Eichler Street, Suite G
Hayward, CA 94545-2783
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
June 3, 2020
Re: CMS # 607103
Dear Mr. Ronald Yu & Mrs. Cathy C. Yu:
On February 27, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at Global Commodities Corp., located at 23759 Eichler Street, Suite G, Hayward, CA 94545. We also conducted an initial inspection of September 12, 2017. These inspections were conducted to determine your firm’s 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 will 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 FSVPs for Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves imported from (b)(4), Philippines; and Boy Bawang Mixed Nuts Snacks – Garlic imported from KSK Food Products, Philippines. Your firm 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 on September 12, 2017 and the follow-up inspection on February 27, 2020, our investigator provided you in each instance a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response sent via email dated March 5, 2020 where you included documents from your foreign supplier, (b)(4), Philippines, such as a HACCP plan entitled “Bottled Tropical Fruit Preserves” dated May 10, 2019 (includes Sugar Palm Fruit and Macapuno String and others) and three SGS Certificates. You also included your document titled, “FSVP Foreign Supplier Verification Activity(ies) Worksheet Example” for “Macapuno Strings” and “Kaong” products. We are unable to evaluate the adequacy of your response because you did not provide details as to how the documents meet the requirements of the FSVP regulation. We address your response in more detail below.
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 Boy Bawang Mixed Nuts Snacks-Garlic manufactured by KSK Food Products, Philippines.
2. For a low-acid canned food not subject to further processing, you did not verify and document the food was produced accordance with the low-acid canned food regulations (part 113), or with respect to all matters not controlled by part 113, you did not have an FSVP, as required by 21 CFR 1.502(b)(1). Specifically, your firm did not document compliance with 21 CFR part 113 or otherwise develop an FSVP for Buenas Kaong Red Sugar Palm Fruit in syrup and Macapuno String in Syrup Preserves manufactured by (b)(4), Philippines.
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 the food products that you import including Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves manufactured by (b)(4) located in Philippines and Boy Bawang Mixed Nuts Snacks – Garlic manufactured by KSK Food Products located in Philippines. We may place the foods you import 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.
In addition to the above violations, we also have the following comments. In response to the Form FDA 483a, you provided FDA with a copy of your foreign supplier’s HACCP plan and SGS Certificates for Food Safety System Certification (ISO 22000), Good Manufacturing Practice (Codex Alimentarius), and HACCP Codex Alimentarius. To meet your obligation under the FSVP regulation, you did not provide FDA with evidence that you conducted a hazard analysis as required by 21 CFR 1.504(a). 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 (21 CFR 1.504(d)). You did not submit your supplier’s hazard analysis or your review and assessment of your supplier’s hazard analysis. Further, the FSVP regulation also generally requires that you evaluate your foreign supplier’s performance and document your approval, as required by 21 CFR 1.505; and conduct foreign supplier verification activities as required by 21 CFR 1.506, among other requirements. You did not provide FDA with evidence that you evaluated or approved your suppliers or conducted verification activities.
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: David Serrano, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Mr. Serrano via email at: david.serrano@fda.hhs.gov. Please reference CMS # 607103 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
Dan R. Solis
Program Division Director
Division of West Coast Imports
FDA WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/h-c-food-inc-607742-06222020
H & C Food Inc.
MARCS-CMS 607742 — June 22, 2020
Recipient:
Sai Lu Pan
Owner & CEO
H & C Food Inc.
1300 Metropolitan Ave.
Brooklyn, NY 11237
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 607742
Dear Ms. Sai Lu Pan:
On April 9, 2020 and April 14, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of H & C Food Inc., located at 1300 Metropolitan Ave, Brooklyn, NY 11237. We also conducted an initial on-site FSVP inspection on August 23, 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 Enoki Mushroom imported from Green Co., Ltd, South Korea and Teriyaki Kimnori Roasted seaweed Snack (b)(4). Your firm 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 most recent inspection on April 14, 2020 and the initial FSVP inspection on August 23, 2018, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your two emailed responses on May 4, 2020, one of which included attachments you describe as being from your “Korean fresh enoki mushroom supplier” and the other from your “Roasted Seaweed supplier (b)(4).” The four documents you associated with your Enoki Mushroom supplier are a Hazard Analysis Critical Control Point (HACCP) plan not translated to English, a Processing Risk Assessment that does not reference a product or company, and a Corrective Action plan and Staff Safety Risk Assessment that both list (b)(4), Green Co. Ltd.). The two documents you associated with your Teriyaki Kimnori Roasted seaweed Snack supplier are a HACCP plan for roasted products and copies of nutritional labeling for seasoned seaweed. We are unable to evaluate the adequacy of this response because you did not provide your review of these documents or how they would apply to your FSVP for these products. We also received your email on April 29, 2020, where you provided attachments related to your frozen rice balls and pears imported from (b)(4), which were not covered during our inspection.
Your significant violations of the FSVP regulation are as follows:
You did not meet your requirements to conduct a hazard analysis for your Enoki Mushroom imported from Green Co., Ltd., located in South Korea and your Teriyaki Kimnori Roasted seaweed Snack imported from (b)(4) in accordance with 21 CFR 1.504 because you did not evaluate your foreign suppliers’ performance in accordance with 21 CFR 1.505, nor did you perform foreign supplier verification activities in accordance with 21 CFR 1.506. Specifically, you did not document your review and assessment of your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d). The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements.
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 the Enoki Mushroom imported from Green Co. Ltd., South Korea, and Teriyaki Kimnori Roasted seaweed Snack imported (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.
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 revised 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). Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) david.trent-carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at david.trent-carlson@fda.hhs.gov. Please reference CMS # 607742 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/
Dawne Hines
Program Division Director
Division of Northeast Imports
FDA WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/diamond-rock-food-imports-inc-607128-06082020
Diamond Rock Food Imports Inc.
MARCS-CMS 607128 — June 08, 2020
Recipient:
Wesley E. Alvarado CEO
Diamond Rock Food Imports Inc.
1199 Sunrise Hwy Ste 2-3
Copiague, NY 11726
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 607128
June 8, 2020
Dear Mr. Wesley Alvarado:
On March 9, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at Diamond Rock Food Imports, Inc. located at 1199 Sunrise Hwy Ste 2-3 Copiague, NY. We also conducted an initial inspection on September 22, 2017. 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 Tomato Sauce and Refried Red Beans products you import from your (b)(4) the Grape Soft Drink product you import from your (b)(4). Your firm did not have an FSVP for these products or any other products imported by your firm. 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 9, 2020, our investigator provided you with a Form FDA 483a, FSVP Observations. We received your email dated April 2, 2020, stating that you intended to respond to our most recent Form 483a, but, to date, we have not received your response to either Form 483a.
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 the following foods:
• Tomato Sauce manufactured by (b)(4)
• Refried Red Beans manufactured by (b)(4)
• Grape Soft Drink manufactured by (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 the food products you import. We may place the foods you import 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.
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 revised 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: Slater Bartlett, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) slater.bartlett@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Bartlett via email at slater.bartlett@fda.hhs.gov. Please reference CMS # 607128 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/
Dawne Hines
Program Division Director
Division of Northeast Imports
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