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WARNING LETTER

Akshar Sales LLC MARCS-CMS 615274 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Gautam T. Patel
Recipient Title
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

 
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