The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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. J&R Produce Inc. Houston, TX The FDA has warned a food firm in Texas about violations of the Foreign Supplier Verification Programs (FSVP) regulation.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.
In a May 28, 2024 warning letter, the FDA described a March 13-14, 2024, FSVP inspection of J&R Produce Inc. in Houston, TX. At the conclusion of the inspection, the FDA investigator provided the firm with a Form FDA 483a FSVP Observations.
Some of the significant violations of t he FSVP regulation are as follows: The firm did not develop, maintain, and follow an FSVP, as required. Specifically, they did not develop an FSVP for any of the foods that you import, including the following foods: During FDA inspection they provided an audit certificate for (redacted by FDA) , which is described as a packing house operation on the audit certificate. A foreign supplier of an article of food is the establishment that manufact.
