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.
La Ilusion Fresh
Oak Lawn, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In a May 12, 2022 warning letter, the FDA described a March 4, 2022, Foreign Supplier Verification Program (FSVP) inspection of La Ilusian Fresh Guava Inc. in Oak Lawn, 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 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:
- Fresh Guava imported from (redacted)
- Fresh Guava imported from (redacted)
- Fresh Guava imported from (redacted)
- Fresh Pitaya / Dragon Fruit imported from (redacted)
The full warning letter can be viewed here.
Krishna Trading LLC
Schaumburg, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In a May 13, 2022 warning letter, the FDA described a Feb. 9-10, 2022, Foreign Supplier Verification Program (FSVP) inspection of Krishna Trading LLC in (redacted).
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) Bhakharwadi imported from (redacted)
• Cumin and black pepper flavored lentil crackers imported from (redacted)
• Veg Noodles imported from (redacted)
The full warning letter can be viewed here.
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