FDA WARNING_LETTER - SERGIO CARRANZA DBA MR CHESCOS - August 25, 2021

On February 3, 2022, the FDA issued a Warning Letter to SERGIO CARRANZA DBA MR CHESCOS following a Foreign Supplier Verification Programs (FSVP) inspection conducted from June 28 to August 25, 2021, at their Houston, Texas location. A previous inspection occurred on August 8, 2018. The inspection found the company non-compliant with Section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR Part 1, Subpart L).

The primary violation identified was the failure to develop, maintain, and follow an FSVP for imported foods, including cola, grape, and banana flavored carbonated soft drinks. The company received a Form FDA 483a on August 25, 2021. Their September 9, 2021, response, stating they would "look for someone who knows about this system," was deemed insufficient as it lacked documentation of corrective action.

The FDA warned that continued non-compliance could lead to refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, potentially resulting in detention without physical examination (DWPE) via Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under Section 301(zz) of the