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.

Promex Distribution LLC, McAllen, TX
Omar Salazar Cavazos

In an April 13, 2020, warning letter the FDA described an Aug. 23, 2018, Foreign Supplier Verification Program (FSVP) inspection at Promex Distribution LLC, as well as a second inspection on Feb. 11, 2020. Inspectors found that the company was not in compliance with FSVP regulation.

FDA’s inspection resulted in issuance of an FDA Form 483 inspectional report form.

The significant violations of the FSVP regulation 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:

  • Carbonated mineral water manufactured by (redacted) and imported under entry (redacted).
  • Cornmeal manufactured by (redacted) and imported under entry (redacted).

The full warning letter can be viewed here.

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