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.


Campimex, Inc.

McAllen, TX

An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.

In a Dec. 11 warning letter, the FDA described a June 30 and July 2, 2020, Foreign Supplier Verification Program (FSVP) inspection of FSVP records Campimex Inc. submitted electronically. 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 firm’s significant violations of the FSVP regulation are as follows:

  1. The firm must conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring control. Their hazard analysis identified and evaluated hazards that may be present from the point after their suppliers load and ship the products they import, including frozen sliced strawberries from (redacted). However, the firm did not identify or evaluate biological, chemical, or physical hazards that may be present before their suppliers load the products they import. The FDA notes that having a complete hazard analysis is essential to conducting a proper evaluation of their foreign supplier under 1.505 and determining and conducting appropriate verification activities.

  2. The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved based on their evaluation conducted to determine a foreign supplier’s performance and the risk posed by the food.

  3. The firm did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the food they import.

In addition to the above violations, the FDA also had the following comments: The FDA notes that under 21 CFR 1.501(b)(1), 21 CFR part 1 subpart L does not apply with respect to juice products that are imported from a foreign supplier that is required to comply with and is in compliance with, the requirements in 21 CFR part 120. If the firm imports juice products that are subject to 21 CFR part 120, they must comply with the requirements applicable to importers of those products under 21 CFR 120.14.  Based on the documents they provided during our FSVP inspection it appears they are not in compliance with 21 CFR 120.14 because they did not have and implement written procedures for ensuring that the juice they import into the United States was processed in accordance with the requirements of 21 CFR part 120 with respect to their juice product Frozen Mango Pulp imported from their foreign supplier, (redacted).

The full warning letter can be viewed here.

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