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.
Africana Market LLC
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported Egusi Seed Paste, Instant Noodles, and Ogbono Nut Meal.
In an April 29 warning letter, the FDA described a Feb. 9 to March 11 Foreign Supplier Verification Program (FSVP) inspection of Africana Market LLC in Aurora, 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.
The firm’s significant violations of the FSVP regulation are as follows:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop, maintain, and follow an FSVP for their Egusi Seed Paste, Instant Noodles, and Ogbono Nut Meal imported from (redacted).
On February 27, the firm emailed FDA investigators a single lab analysis report for “(redacted) EGUSI,” for “(redacted) OGBONO,” and for “(redacted) INSTANT NOODLES.” The firm did not provide an explanation of these documents, describe how they would apply to their FSVP program, state that they constitute their FSVP program, or provide a record of their review of these documents. These documents alone do not constitute an FSVP as required.
“We note that you (redacted).”
The full warning letter can be viewed here.
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