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.
Flores Produce Inc.
Chula Vista, 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 June 24, 2022, warning letter the FDA described a March 8-11, 2022, Foreign Supplier Verification Program (FSVP) inspection of Flores Produce Inc. in Chula Vista, 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:
- Papayas imported from (redacted)
Additional comments:
The firm imports papayas, which are “covered produce.” Their FSVP must demonstrate that their supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
The full warning letter can be viewed here.
North30 LLC
Bellevue, WA
An import company in Washington is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 24, 2022, warning letter, the FDA described a March 14 through April 8, 2022, Foreign Supplier Verification Program (FSVP) inspection of North30 LLC in Bellevue, WA.
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:
- Passion Fruit Sauce, imported from (redacted), located in (redacted)
- Taro, imported from (redacted) located in (redacted)
- Mesona Extract, imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
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