The US Food and Drug Administration sends warning letters to food companies with import violations

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some messages are not made public until weeks or months after they are sent. Business owners have 15 days to respond to warning letters from the Food and Drug Administration. Warning letters are often not issued until the company has been given months to years to correct problems.


Subluxme Grocery
Houston, Texas

An import company in Texas received a notification from the U.S. Food and Drug Administration (FDA) of a lack of FSVPs for a number of imported food products.

In a warning letter dated May 2, the US Food and Drug Administration (FDA) described an inspection dated December 13, 2021 through January 18, 2022, examining the Foreign Supplier Verification Program (FSVP) of Subhlaxmi grocers in Houston, Texas.

An FDA examination revealed that the company was not in compliance with FSVP regulations and led to the release of FDA Form 483a. The grave violations were as follows:

The company did not develop, maintain, and follow FSVP. Specifically, they did not develop an FSVP for the food products they import:

  • Summer squash imported from (revised)
  • sweet goods imported from (revised)
  • Grain preparations imported from (revised)
  • Snacks imported from (revised)
  • Dry mix prepared imported from (revised)
  • Corn flakes, puffs, krispies, rings imported from (revised)
  • Potato snacks and vegetarian snacks imported from (revised)
  1. The company must perform a risk analysis for each type of food it imports to determine if there are any risks that require control. for turmeric powder from (revised) And a powdered mixture of cumin, coriander, potato and galli wafer (revised), did not meet the requirement to perform a hazard analysis. They must document their review and evaluation of the risk analysis, including documentation that the risk analysis was performed by a qualified individual. During the examination, they provided the risk analyzes, obtained from their foreign suppliers, for turmeric powder from (revised) The powder of a mixture of cumin, coriander and potato slices is galli from (revised). However, they did not provide FDA documentation that they reviewed and evaluated for the risk analyzes of their foreign suppliers for any of these products, including documentation that each risk analysis was performed by a qualified individual.
  2. To get turmeric powder from (revised) The powder of a mixture of cumin, coriander and potato slices is galli from (revised)The company did not meet the requirements for evaluating the performance of its foreign suppliers and the risks posed by food. They must document their review and evaluation, including documentation that the evaluation was made by a qualified individual. During the examination, provide a one-page cover sheet for each of the following products: Turmeric powder from (revised) The powder of a mixture of cumin, coriander and potato slices is galli from (revised). Each cover sheet includes a placeholder for approval and signature (revised). In addition to being unsigned, the documentation they provided does not indicate that the factors described in 21 CFR 1.505(a) were taken into account when evaluating these foreign suppliers and the risks these foods pose. Moreover, to the extent that (revised) another entity, and they wish to rely on its evaluation to meet the requirements, and have not provided documentation that they have reviewed and evaluated its evaluation, including documentation that the evaluation was made by a qualified individual
  3. The company did not meet the requirements to perform verification activities of foreign suppliers. Specifically, for turmeric powder from (revised) The powder of a mixture of cumin, coriander and potato slices is galli from (revised), they have not fulfilled the requirements, prior to importing foods from these foreign suppliers, to identify and document the verification activity or activities, as well as to repeat the activity or activities to be undertaken, to provide sufficient assurance that the foods they obtain from these foreign suppliers are being produced. Likewise, for foods imported by these foreign suppliers, they did not conduct or document (or obtain documentation) one or more supplier verification activities for each foreign supplier prior to importing the food and periodically thereafter.

The full warning letter can be viewed over here.

Coastal Fresh Farms Inc.
Westlake Village, California

An import company in California received a notification from the U.S. Food and Drug Administration (FDA) of a lack of FSVPs for a number of imported food products.

In a warning letter dated May 11, the US Food and Drug Administration (FDA) described an inspection from January 31 through February 9, 2022, the Coastal Fresh Farms Inc.’s Foreign Vendor Verification Program (FSVP). in Westlake Village, CA.

An FDA examination revealed that the company was not in compliance with FSVP regulations and led to the release of FDA Form 483a. The grave violations were as follows:

The company did not develop, maintain, and follow FSVP. Specifically, they did not develop an FSVP for any of the foods they import, including:

  • Coriander imported from (revised)
  • green onions imported from (revised)
  • Parsley curly imported from (revised)

Additionally, the Food and Drug Administration provided the following comment:

The company imports raw agricultural products, which are “covered products”. Their FSVP must demonstrate that their suppliers comply with the requirements of standards for growing, harvesting, packaging and holding products for human consumption.

The full warning letter can be viewed over here.

Allure Foods LLC
Brooklyn, New York

An import company in New York has received a notification from the US Food and Drug Administration (FDA) of a lack of FSVPs for a number of imported food products.

In a warning letter dated April 27, the U.S. Food and Drug Administration (FDA) described an examination from November 23 to December 6, 2021, the Foreign Supplier Verification Program (FSVP) screening of Allure Foods LLC in Brooklyn, New York.

An FDA examination revealed that the company was not in compliance with FSVP regulations and led to the release of FDA Form 483a. The grave violations were as follows:

The company did not develop, maintain, and follow FSVP. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following food products:

  • Cashew nuts are imported from their foreign suppliers (revised) located in (revised)
  • Roasted/salted beans and natural peas imported from their foreign suppliers (revised)located in (revised)

The full warning letter can be viewed over here.

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