Food firms in California, Illinois warned about lack of documents for imports

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. The FDA frequently redacts parts of warning letters posted for public view.

Akshar Sales LLC
Fremont, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Aug. 16 warning letter, the FDA described an Apr. 22-28 Foreign Supplier Verification Program (FSVP) inspection of Akshar Sales LLC of Fremont, 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. Two of the significant violations are as follows:

1. The firm must conduct a hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, they must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. During FDA inspection they provided a hazard analysis obtained from their foreign supplier for their Chai Biscuits and Fruit Biscuits imported from (redacted), and (redacted) vermicelli imported from (redacted). However, for each of these products, they did not provide documentation that they have reviewed and assessed their foreign supplier’s hazard analysis as required.
2. The firm did not approve their foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food and document their approval. Specifically, for their foreign suppliers, (redacted) and (redacted), they did not document their evaluation of the foreign suppliers’ performance in accordance with regulation or their approval of these suppliers.
3. The firm did not establish and follow written procedures to ensure that they import foods only from approved foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food and document their use of these procedures. Specifically, they have not established written procedures for approving foreign suppliers for any of their imported foods.
4. The firm did not meet the requirements to perform foreign supplier verification activities in accordance with regulations for the products they import. Specifically, the firm did not document their determination or performance of appropriate supplier verification activities for the Chai Biscuits and Fruit Biscuits imported from (redacted), and (redacted) vermicelli imported from (redacted). The firm did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with FDA regulation, they did not document their determination of the appropriate supplier verification activity, and they did not document (or obtain documentation of) performance 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.

Garden Fresh Market
Buffalo Grove, IL

An import company in Buffalo Grove, IL, is on notice from the FDA for not having FSVPs for a number of imported food products.

In an Aug. 4 warning letter, the FDA described a March 22 to 30, 2021, Foreign Supplier Verification Program (FSVP) inspection of Garden Fresh Market in Buffalo Grove, IL. The FDA also conducted an inspection on July 25, 2019, and found similar problems as the recent review.

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 as required. Specifically, they did not develop an FSVP for each of the following foods:

• Pickled tomatoes imported from (redacted), located in (redacted)
• Pickled tomatoes and cucumbers imported from (redacted), located in (redacted)
• Half sour pickles imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

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