Two food importers were issued Warning Letters for failure to implement FSVP for the products these companies were importing. The FSVP regulation requires that importers perform certain risk-based activities (a hazard analysis and appropriate approval and verification 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.
As we often see, importers and companies who purchase importers are often unaware of these requirements. Penn State and other trainers provide FSPCA's FSVP training, a two day event that covers the requirements of the regulation.
Akshar Sales, LLC, of Fremont, CA
While the foreign supplier provided a hazard analysis obtained for imported Chai Biscuits and Fruit Biscuits and Vermicelli, the importer did not provide documentation that these were reviewed and assessed 2) The company did not approve foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food 3) The company did have not established written procedures for approving foreign suppliers for any of your imported foods.4) the importer did not document a determination or performance of appropriate supplier verification activities, did not establish written procedures for ensuring that appropriate supplier verification activities, did not document the determination of the appropriate supplier verification activity, and did not document (or obtain documentation of) performance of one or more of the supplier verification activitiesGarden Fresh Market of Buffalo Grove, IL
The company did not develop, maintain, and follow an FSVP as required for imported pickled tomatoes, pickled tomatoes and cucumbers, and half sour pickles. The company indicated that they were not planning to import any further product.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akshar-sales-llc-615274-08162021
Akshar Sales LLC
MARCS-CMS 615274 — AUGUST 16, 2021
Recipient:
Mr. Gautam T. Patel
President/Sole Owner
Akshar Sales LLC
4807 Davenport Place
Fremont, CA 94538
United States
Issuing Office:
Division of West Coast Imports
United States
August 16, 2021
WARNING LETTER
Re: CMS #615274
Dear Mr. Patel:
On April 22, 2021 through April 28, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Akshar Sales, LLC, located at 4807 Davenport Place, Fremont, CA 94538. We also conducted an inspection from September 7, 2018 through September 13, 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 Foreign Supplier Verification Program (FSVP) implementing 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/GuidanceRegulation/FSMA/ucm361902.htm
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for foods you import including, but not limited to, Chai Biscuits and Fruit Biscuits imported from (b)(4), and (b)(4) Vermicelli imported from (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the FSVP inspection on April 28, 2021, our investigator provided you with Form FDA 483a, FSVP Observations.
We have not received your response to the Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
1. You must conduct a hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504(a). Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). During our inspection you provided a hazard analysis obtained from your foreign supplier for your Chai Biscuits and Fruit Biscuits imported from (b)(4), and (b)(4) Vermicelli imported from (b)(4). However, for each of these products, 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).
2. You did not 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). Specifically, for your foreign suppliers, (b)(4) and (b)(4), you did not document your evaluation of the foreign supplier’s performance in accordance with 21 CFR 1.505(a)(2) or your approval of these suppliers in accordance with 21 CFR 1.505(b).
3. You did not establish and follow written procedures to ensure that you import foods only from approved 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 21 CFR 1.506(a)(1). Specifically, you have not established written procedures for approving foreign suppliers for any of your imported foods.
4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for the Chai Biscuits and Fruit Biscuits imported from (b)(4), and (b)(4) Vermicelli imported from (b)(4). You did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), you did not document your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d), and you did not document (or obtain documentation of) performance 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).
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.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you do not adequately address this matter, 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 you import for which you appear to be in violation of section 805. 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 any 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 revised 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: Dennis N. Hoang, 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 Compliance Officer Hoang via email at dennis.hoang@fda.hhs.gov. Please reference CMS # 615274 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/
Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports
One World Trade Center, Suite 300
Long Beach, CA 90831
Garden Fresh Market - 614397 - 08/04/2021 | FDA
Garden Fresh Market
MARCS-CMS 614397 — AUGUST 04, 2021
Recipient:
Golan Mor
Owner
Garden Fresh Market
770 South Buffalo Grove Rd.
Buffalo Grove, IL 60089
United States
Issuing Office:
Division of Northern Border Imports
United States
August 4, 2021
WARNING LETTER
Re: CMS # 614397
Dear Mr. Golan Mor:
On March 22 through 30, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Garden Fresh Market located at 770 South Buffalo Grove Rd., Buffalo Grove, IL 60089. We also conducted an inspection on July 25, 2019. 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 Foreign Supplier Verification Program (FSVP) implementing 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-supplierverification-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 pickled tomatoes, pickled tomatoes and cucumbers, and half sour pickles that you import from (b)(4), located in (b)(4). You did not have FSVPs for these products or for any foods that you import. 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 July 25, 2019, and the follow-up inspection on March 30, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your responses dated September 10, 2019, and April 16, 2021, and we address your responses below.
On September 10, 2019, following the initial inspection, you stated that you were “not planning to import any product” at this time and would “[d]o all paper work” before importing again. We noted in response to your email that if your firm imports food, you must follow the pertinent FSVP requirements before importing the food. You continued to import food after September 10, 2019.
In your April 16, 2021 response to the most recent inspection, you stated that you will no longer buy direct from your foreign supplier (b)(4) in (b)(4) and will only use “local distributors.” We note that you made a similar statement in response to our initial 483a, FSVP Observations, issued on July 25, 2019, without making any corrections or developing an FSVP for the foods you imported. If you continue to import food from foreign suppliers, you must develop an FSVP for each of the foods you import.
Your significant violation of the FSVP regulation is 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 each of the following foods:
• Pickled tomatoes imported from (b)(4), located in (b)(4);
• Pickled tomatoes and cucumbers imported from (b)(4), located in (b)(4); and
• Half sour pickles imported from (b)(4), located in (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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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 https://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 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 email your reply to Food and Drug Administration, Attention: Erica Koory, Compliance Officer, Division of Northern Border Imports, at erica.koory@fda.hhs.gov. Please reference CMS # 614397 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/
Sherea L. Dillon for Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
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 any 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 revised 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: Dennis N. Hoang, 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 Compliance Officer Hoang via email at dennis.hoang@fda.hhs.gov. Please reference CMS # 615274 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/
Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports
One World Trade Center, Suite 300
Long Beach, CA 90831
Garden Fresh Market - 614397 - 08/04/2021 | FDA
Garden Fresh Market
MARCS-CMS 614397 — AUGUST 04, 2021
Recipient:
Golan Mor
Owner
Garden Fresh Market
770 South Buffalo Grove Rd.
Buffalo Grove, IL 60089
United States
Issuing Office:
Division of Northern Border Imports
United States
August 4, 2021
WARNING LETTER
Re: CMS # 614397
Dear Mr. Golan Mor:
On March 22 through 30, 2021, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Garden Fresh Market located at 770 South Buffalo Grove Rd., Buffalo Grove, IL 60089. We also conducted an inspection on July 25, 2019. 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 Foreign Supplier Verification Program (FSVP) implementing 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-supplierverification-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 pickled tomatoes, pickled tomatoes and cucumbers, and half sour pickles that you import from (b)(4), located in (b)(4). You did not have FSVPs for these products or for any foods that you import. 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 July 25, 2019, and the follow-up inspection on March 30, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your responses dated September 10, 2019, and April 16, 2021, and we address your responses below.
On September 10, 2019, following the initial inspection, you stated that you were “not planning to import any product” at this time and would “[d]o all paper work” before importing again. We noted in response to your email that if your firm imports food, you must follow the pertinent FSVP requirements before importing the food. You continued to import food after September 10, 2019.
In your April 16, 2021 response to the most recent inspection, you stated that you will no longer buy direct from your foreign supplier (b)(4) in (b)(4) and will only use “local distributors.” We note that you made a similar statement in response to our initial 483a, FSVP Observations, issued on July 25, 2019, without making any corrections or developing an FSVP for the foods you imported. If you continue to import food from foreign suppliers, you must develop an FSVP for each of the foods you import.
Your significant violation of the FSVP regulation is 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 each of the following foods:
• Pickled tomatoes imported from (b)(4), located in (b)(4);
• Pickled tomatoes and cucumbers imported from (b)(4), located in (b)(4); and
• Half sour pickles imported from (b)(4), located in (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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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 https://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 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 email your reply to Food and Drug Administration, Attention: Erica Koory, Compliance Officer, Division of Northern Border Imports, at erica.koory@fda.hhs.gov. Please reference CMS # 614397 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/
Sherea L. Dillon for Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
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