FDA warns 2 companies about import violations

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.

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Kyawkhin Inc.
Fort Wayne, IN

A food firm in Indiana is on notice from the FDA for not having FSVPs for several imported food products.

In a Sept. 20, 2023, warning letter, the FDA described an Aug. 15-17, 2023, Foreign Supplier Verification Program (FSVP) inspection of Kyawkhin Inc. in Fort Wayne, IN.

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:

• Balachong fried chili paste imported from (redacted), located in (redacted)
• Peanut snack imported from (redacted), located in (redacted)
• Cypro tone beverage base imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

Distribuidora Jocorena Inc.
Deer Park, NY

A food firm in New York is on notice from the FDA for not having FSVPs for several imported food products.

In a Nov. 30, 2023, warning letter, the FDA described an Aug. 21 through Sept. 8, 2023, Foreign Supplier Verification Program (FSVP) inspection of Distribuidora Jocorena Inc. in Deer Park, 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:

• Pinole (corn flour) imported from (redacted), located in (redacted)
• Frozen corn tamale imported from (redacted), located in (redacted)
• Dry red beans (kidney beans) imported from (redacted), located in (redacted)

The full warning letter can be viewed here.

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