FDA 483 - Heres Distributors, LLC - September 01, 2023

Heres Distributors, LLC, based in McAllen, TX, was inspected by the FDA on September 1, 2023. The inspection specifically reviewed the company's adherence to the Foreign Supplier Verification Program (FSVP) requirements, which fall under the regulatory framework of Section 805 of the Federal Food, Drug and Cosmetic Act. The primary violation identified was the company's failure to develop an FSVP. This issue is a repeat observation, having been cited in previous inspections on February 25, 2020, July 12, 2022, and February 16, 2023, highlighting a persistent lack of compliance.

Specifically, Heres Distributors, LLC confirmed the absence of an FSVP for several imported products, including caramel candy, spices/seasoning candy, mole paste/sauces, chocolate covered candy, and apple cider vinegar. Furthermore, the company stated that no FSVP was in place for any food imported between August 1, 2022, and July 31, 2023. The required action for the company is to promptly develop and implement a comprehensive Foreign Supplier Verification Program to ensure imported foods meet U.S. safety standards, thereby addressing this critical and recurring regulatory deficiency.