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.
Del Valle Import & Export 3, Inc. DBA El Progreso Imports
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a July 18, 2023, warning letter, the FDA described a Feb. 22-28, 2022, Foreign Supplier Verification Program (FSVP) inspection of Del Valle Import & Export 3, Inc. dba El Progreso Imports in Vernon, CA.
The FDA also conducted inspections from Sept. 7-13, 2022, Feb. 4 through March 5, 2021, and Feb. 6-12, 2019. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act and the FSVP implementing regulation.
The FDA’s most recent 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, as required. Specifically, they did not develop an FSVP for the foods from the foreign suppliers indicated in the list provided during the inspection.
- The firm’s written response dated March 20, 2023, provided FSVP records from their current consultant for their Corn Chip Snacks, imported from (redacted). The firm also provided FSVP records from 2020 and 2021 from their previous consultant for their Plantain Chips imported from (redacted) and Banana Soft Drink imported from (redacted). However, their written response did not provide records for any other products they import. The firm’s written response also stated that they were taking a number of actions to show that they are in the process of (redacted). However, the FDA cannot evaluate the adequacy of these corrective actions because their written response does not indicate that they have completed any of these actions or provided a timeframe for doing so. The FDA will evaluate the adequacy of any corrective actions at the next FSVP inspection.
The full warning letter can be viewed here.
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