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.
Don’t Run Out dba Public Goods
New York, 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 a March 11 warning letter, the FDA described a Nov. 23 through Dec. 30, 2021, Foreign Supplier Verification Program (FSVP) inspection of Don’t Run Out dba Public Goods in New York, 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:
- (Redacted) ramen noodles from (redacted).
The full warning letter can be viewed here.
Madres Groceries
Sunnyvale, 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 March 28 warning letter the FDA described a Dec. 17, 2021, and Jan. 3-5, 2022, Foreign Supplier Verification Program (FSVP) inspection of Madres Groceries in Sunnyvale, 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 each of the following foods:
- Snack – Butter Murukku – imported from (redacted) in (redacted)
- Snack – Banana Chips – imported from (redacted) in (redacted)
- Snack – (Redacted) – imported from (redacted) in (redacted)
The full warning letter can be viewed here.
SCO Koladen LLC
Livermore, 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 April 14 warning letter, the FDA described a Dec. 1 through 7, 2021, Foreign Supplier Verification Program (FSVP) inspection of SCO Koladen LLC in Livermore, 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 each of the following foods:
- (Redacted) Milk Chocolate with Almonds imported from (redacted), located in (redacted)
- (Redacted) imported from (redacted), located in (redacted)
- Advent Calendar with chocolate pieces imported from (redacted), located in (redacted)
During FDA inspection the firm provided three documents which they obtained from their foreign suppliers: a “FSMA” document for (redacted); an Audit Report for (redacted); and a Food Safety Plan for (redacted). However, the documents that are relevant to an FSVP are incomplete, and they did not provide a record of their review of the relevant documents or explain how they would apply to their FSVP program.
The full warning letter can be viewed here.
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