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WARNING LETTER

Subhlaxmi Grocers MARCS-CMS 628829 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Animesh Patel
Recipient Title
Owner
Subhlaxmi Grocers

6660 Southwest Fwy
Houston, TX 77074-2210
United States

Issuing Office:
Division of Southwest Imports

United States


May 2, 2022

WARNING LETTER

Re: CMS # 628829

Dear Mr. Animesh Patel:

On December 13, 2021, through January 18, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Subhlaxmi Grocers located at 6660 Southwest Fwy, Houston, Texas. We also conducted an inspection April 15, 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 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 potato wafer jali, cumin coriander mix powder, summer squash, sweet goods, cereal preparations, snack foods, cake prepared dry mix, corn flakes, puffs, krispies, loops, potato snacks, and vegetable snacks imported from your foreign supplier (b)(4) located in (b)(4); and your turmeric powder imported from your foreign supplier (b)(4) located in (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 inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on January 18, 2022.

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, you did not develop an FSVP for the following foods you import:

  • summer squash imported from (b)(4)
  • sweet goods imported from (b)(4)
  • cereal preparations imported from (b)(4)
  • snack foods imported from (b)(4)
  • cake prepared dry mix imported from (b)(4)
  • corn flakes, puffs, krispies, loops imported from (b)(4)
  • potato snacks and vegetable snacks imported from (b)(4)

2. 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). For the turmeric powder from (b)(4) and the cumin coriander mix powder and the potato wafer jali from (b)(4), you did not meet the requirement to conduct a hazard analysis in accordance with 21 CFR 1.504. Although you may meet the requirements of 21 CFR 1.504 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 the inspection, you provided hazard analyses, obtained from your foreign suppliers, for the turmeric powder from (b)(4) and the cumin coriander mix powder and the potato wafer jali from (b)(4). However, you did not provide FDA documentation that you reviewed and assessed your foreign suppliers’ hazard analyses for any of these products, including documenting that each hazard analysis was conducted by a qualified individual, as required by 21 CFR 1.504(d).

3. For the turmeric powder from (b)(4) and the cumin coriander mix powder and the potato wafer jali from (b)(4), you did not meet the requirement to evaluate your foreign supplier’s performance and the risk posed by the food, as required by 21 CFR 1.505. Although you may meet the requirements of 21 CFR 1.505 by reviewing and assessing the evaluation conducted by another entity other than the foreign supplier, using a qualified individual and considering the factors described in 21 CFR 1.505(a), you must document your review and assessment, including documenting that the evaluation was conducted by a qualified individual. During the inspection, you provided a one-page cover sheet for each of the following products: the turmeric powder from (b)(4) and the cumin coriander mix powder and the potato wafer jali from (b)(4). Each cover sheet includes a placeholder for an approval and signature by (b)(4). In addition to being unsigned, the documentation you provided does not indicate that the factors described in 21 CFR 1.505(a) were considered in evaluating these foreign suppliers and the risk posed by these foods, as required by 21 CFR 1.505. Further, to the extent that (b)(4) is another entity, and you wish to rely on his evaluation to satisfy the requirements of 21 CFR 1.505, you did not provide documentation that you reviewed and assessed his evaluation, including documenting that the evaluation was conducted by a qualified individual, as required by 21 CFR 1.505(d).

4. You did not meet the requirements to perform foreign supplier verifications activities in accordance with 21 CFR 1.506. Specifically, for the turmeric powder from (b)(4) and the cumin coriander mix powder and the potato wafer jali from (b)(4), you did not meet the requirements to, before importing the foods from these foreign suppliers, determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the foods you obtain from these foreign suppliers are produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). Likewise, for these foods imported by these foreign suppliers, 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).

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. 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 foods. 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 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 working 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: Melissa G. Gonzalez, Compliance Officer, the Division of Southwest Imports, 216 West Village Blvd, Suite 107, Laredo, Texas 78041. If you have any questions regarding this letter, you may contact Melissa G. Gonzalez via email at melissag.gonzalez@fda.hhs.gov. Please reference CMS # 628829 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/

Todd Cato
Division Director
Division of Southwest Imports

 
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