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.
Golden Natural Products
Forest Hills, NY
An import company in New York is on notice from the FDA for not having a Foreign Supplier Verification Program (FSVP) for a number of imported food products.
In an Oct. 5, 2023, warning letter, the FDA described a July 11-13, 2023, FSVP inspection of Golden Natural Products in Forest Hills, 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 each of the following foods:
• Dried Apricots Subkhani from (redacted) located in (redacted).
• Dried Cherry Plums from (redacted) located in (redacted)
• Noodles from (redacted) located in (redacted)
The full warning letter can be viewed here.
American Distribution and Manufacturing Co., LLC
Cottage Grove, MN
An import company in Minnesota is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 12, 2023, warning letter, the FDA described an April 13 through May 12, 2023, Foreign Supplier Verification Program (FSVP) inspection of American Distribution and Manufacturing Co., LLC in Cottage Grove, MN.
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 each of the following foods:
- Dry kibble cat food (poultry flavor) imported from (redacted), located in (redacted)
- Dry kibble dog food (lamb/venison flavor) imported from (redacted), located in (redacted)
- (Redacted) feed additive (diatomaceous earth feed additive) imported from (redacted), located in (redacted)
The firm must also conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring a control, as required. Although they may meet their requirement to determine whether there are any hazards requiring a control 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 a qualified individual conducted the hazard analysis. Specifically, during the inspection they provided the written hazard analysis from their foreign supplier for their (redacted) feed additive (diatomaceous earth feed additive) imported from (redacted). However, they did not provide the FDA with any documentation that they reviewed and assessed their foreign supplier’s hazard analysis, as required.
The full warning letter can be viewed here.
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