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.
Global LC Inc. dba Rice Chicken
San Diego, 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 Feb. 4, 2022, warning letter the FDA described a Nov. 3-16, 2021, Foreign Supplier Verification Program (FSVP) inspection of Global LC Inc. dba Rice Chicken in San Diego, 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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Batter mix imported from (redacted) located in (redacted)
- Yang Neum sauce (Mild taste marinade) and roasted seasoning imported from (redacted) located in (redacted)
The full warning letter can be viewed here.
Apna Foods Imports Co.
Addison, IL
An import company in Illinois is on notice from the FDA for significant violations of FSVP regulation.
In a March 8, 2022, warning letter the FDA described a Nov. 15 and 30, 2021, Foreign Supplier Verification Program (FSVP) inspection of Apna Foods Imports Co. in Addison, IL.
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. Some of the significant violations are as follows:
- The firm must conduct a hazard analysis for each type of food they import to determine whether there are any hazards requiring a control. During the inspection, they stated that their foreign supplier wrote their FSVP. The firm provided hazard analyses obtained from their foreign supplier, (redacted), for black gram split and semolina. Although they may meet the requirements of 21 CFR 1.504(a) 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. However, they did not provide FDA documentation that they reviewed and assessed their foreign supplier’s hazard analyses for the black gram split and semolina imported from (redacted). The hazard analyses the firm provided for these foods each stated that for potential biological, chemical, and physical hazards, there were no significant potential food safety hazards, yet also identified preventive measures as critical control points to control biological and physical hazards. Therefore, it is unclear if their foreign supplier’s hazard analyses determined whether there are any hazards requiring a control for these foods.
- 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. Specifically, for their foreign supplier (redacted), they did not evaluate their foreign supplier’s performance and risk posed by the food or approve their supplier on the basis of this evaluation and document their approval of the supplier.
- 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, the firm has not established written procedures for approving foreign suppliers for any of their imported foods.
- The firm did not meet the requirements to perform foreign supplier verification activities for the products they import. Specifically, they did not document their determination or performance of appropriate supplier verification activities for the black gram split or semolina imported from (redacted). The firm did not establish written procedures for ensuring that appropriate supplier verification activities are conducted and 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 through (iv) for their foreign supplier (redacted) before importing food and periodically thereafter.
The full warning letter can be viewed here.
GW Food USA Inc.
South El Monte, 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 Dec. 23, 2021, warning letter the FDA described a Sept. 7-27, 2021, Foreign Supplier Verification Program (FSVP) inspection of GW Food USA, Inc. in South El Monte, 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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Organic Soya (redacted) and Organic Soya (redacted) imported from (redacted) located in (redacted)
- Seaweed & Fish Chip imported from (redacted) located in (redacted)
The full warning letter can be viewed here.
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