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.
White Trading Corporation
An import company in Colorado Is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Dec. 15 warning letter, the FDA described July 21-31, 2020, remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records submitted for White Trading Company.
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) Cheese imported from (redacted)
The FDA received an emailed response dated Aug. 21, 2020, where the firm indicated that they had collected documentation from all but one of their foreign suppliers in order to meet their FSVP requirements. They stated that the development of their FSVP procedures and documentation processes was close to completion and should be completed within the next 30 days.
The firm indicated they would share what they had developed with the FDA. Despite contacting them for a follow-up Sep. 17, 2020, to date, the FDA has not received any documentation from the firm.
The full warning letter can be viewed here.
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