As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Subhlaxmi Grocers
Houston, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a May 2 warning letter, the FDA described a Dec. 13, 2021, through Jan. 18, 2022, Foreign Supplier Verification Program (FSVP) inspection of Subhlaxmi Grocers in Houston, TX.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for the food products that they import:
- summer squash imported from (redacted)
- sweet goods imported from (redacted)
- cereal preparations imported from (redacted)
- snack foods imported from (redacted)
- cake prepared dry mix imported from (redacted)
- corn flakes, puffs, krispies, loops imported from (redacted)
- potato snacks and vegetable snacks imported from (redacted)
- The firm must conduct a hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. For turmeric powder from (redacted) and cumin-coriander mix powder and potato wafer jali from (redacted), they did not meet the requirement to conduct a hazard analysis. They must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During the inspection, they provided hazard analyses, obtained from their foreign suppliers, for the turmeric powder from (redacted) and the cumin-coriander mix powder and the potato wafer jali from (redacted). However, they did not provide FDA documentation that they reviewed and assessed their foreign suppliers’ hazard analyses for any of these products, including documenting that each hazard analysis was conducted by a qualified individual.
- For the turmeric powder from (redacted) and the cumin-coriander mix powder and the potato wafer jali from (redacted), the firm did not meet the requirement to evaluate their foreign supplier’s performance and the risk posed by the food. They must document their review and assessment, including documenting that the evaluation was conducted by a qualified individual. During the inspection, they provided a one-page cover sheet for each of the following products: the turmeric powder from (redacted) and the cumin-coriander mix powder and the potato wafer jali from (redacted). Each cover sheet includes a placeholder for approval and signature by (redacted). In addition to being unsigned, the documentation they 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. Further, to the extent that (redacted) is another entity, and they wish to rely on his evaluation to satisfy the requirements, they did not provide documentation that they reviewed and assessed his evaluation, including documenting that the evaluation was conducted by a qualified individual
- The firm did not meet the requirements to perform foreign supplier verification activities. Specifically, for the turmeric powder from (redacted) and the cumin-coriander mix powder and the potato wafer jali from (redacted), they 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 they obtain from these foreign suppliers are produced. Likewise, for these foods imported by these foreign suppliers, they did not conduct and document (or obtain documentation of) one or more of the supplier verification activities for each foreign supplier before importing the food and periodically thereafter.
The full warning letter can be viewed here.
Coastal Fresh Farms Inc.
Westlake Village, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a May 11, warning letter, the FDA described a Jan. 31 through Feb. 9, 2022, Foreign Supplier Verification Program (FSVP) inspection of Coastal Fresh Farms Inc. in Westlake Village, CA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the foods they import, including:
- Coriander imported from (redacted)
- Green onion imported from (redacted)
- Parsley curly imported from (redacted)
Additionally, the FDA offered the following comment:
The firm imports raw agricultural commodity produce, which is “covered produce.” Their FSVP must demonstrate that their supplier is in compliance with the requirements of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
The full warning letter can be viewed here.
Allure Foods LLC
Brooklyn, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In an April 27 warning letter, the FDA described a Nov. 23 to Dec. 6, 2021, Foreign Supplier Verification Program (FSVP) inspection of Allure Foods LLC in Brooklyn, NY.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following food products:
- Cashews imported from their foreign supplier (redacted) located in (redacted)
- Roasted/salted fava beans and natural wasabi peas imported from their foreign supplier (redacted), located in (redacted)
The full warning letter can be viewed here.
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