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  1. Warning Letters

WARNING LETTER

GMS International Foods Inc. MARCS-CMS 609156 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Mushtaq A. Chhotani
Recipient Title
President
GMS International Foods Inc.

18228 Regina Ave.
Torrance, CA 90504
United States

Issuing Office:
Division of West Coast Imports District Compliance Branch (WCID-CB)

United States


Dear Mr. Chhotani:

On April 15-17 and 19-21, 2020, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for the firm, GMS International Foods Inc., located at 16001 S. San Pedro Street, Unit D, Gardena, CA 90248-2543. We also conducted an initial onsite FSVP inspection on April 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-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 your FSVPs for the following food products you import including, but not limited to: Pran Puffed Rice, Pran Kalizera Rice and Pran Flattened Rice you import from your foreign supplier (b)(4) located in (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 FSVP inspections, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated April 26, 2020. You provided the following documents: 06 February 2020 SGS Corrective Action Requests and the manufacturer’s HACCP plans for the Puffed Rice, Flattened Rice, and Aromatic Rice. Each HACCP plan included the product descriptions and process flow charts. We also note that during the inspection, you provided a copy of your Qualified Facility Attestation, however you also stated that based on your total averaged sales over three years, you did not qualify as a very small importer. During the inspection, you did not provide supporting documentation that you meet the definition of a very small importer to our investigator (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 two 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)).

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. Pran Puffed Rice imported from (b)(4), located in (b)(4)
b. Pran Kalizera Rice imported from (b)(4), located in (b)(4)
c. Pran Flattened Rice 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.

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 Pran Puffed Rice, Pran Kalizera Rice and Pran Flattened Rice you import from your foreign supplier (b)(4) located in (b)(4). We may place these 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.

In addition to the above violations, we also have the following comments:

In your response to the FDA 483 you presented FDA with your foreign supplier’s HACCP plan for your puffed rice and flattened rice products (but not your kalizera rice product), as well as for another product called “aromatic rice.” To the extent you intend to rely on copies of your foreign supplier’s HACCP plans for these rice products, we note that you did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis as required per 21 CFR 1.504(d). 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).

Furthermore, you did not provide documentation that you have met the requirements to evaluate your foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), nor did you document your approval on the basis of that evaluation, as required by 21 CFR 1.505(b). Specifically, you did not document your approval of your foreign supplier of the Pran Puffed Rice, Pran Kalizera Rice, and Pran Flattened Rice imported from (b)(4), as required by 21 CFR 1.505(b). You did not provide documentation showing that you have established and followed written procedures to ensure 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, nor have you documented your use of these procedures, as required by 1.506(a)(1). You also did not provide documentation showing that you have established and followed 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).

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: William J Park, 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 William Park via email at william.park@fda.hhs.gov. Please reference CMS #609156 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/
for Dan R. Solis
Program Division Director
Division of West Coast Imports

 
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