FDA WARNING_LETTER - Gary’s Cheesecakes & Fine Desserts - February 15, 2023

The FDA inspected a ready-to-eat (RTE) bakery products manufacturing facility at 5285 Crookshank Road, Cincinnati, Ohio, from January 31 to February 15, 2023. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), resulting in the RTE bakery products being deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

A key violation was the failure to effectively exclude pests, specifically rodents, from the facility (21 CFR § 117.35(c)). This was a repeat observation from a 2020 FDA inspection, with rodent excrement found on and around an in-use caramel container and on a shelf. The firm's March 7, 2023, response, detailing disposal of traps, cleaning, and scheduled maintenance, was deemed inadequate as it did not demonstrate continuous implementation or effective pest exclusion. Previous corrective actions from 2020 were also ineffective. The FDA noted the firm's failure to acquire professional pest control services despite discussions during the inspection.

Additionally, the facility failed to renew its food facility registration as required by section 415 of the Act and 21 CFR Part 1, Subpart H, a prohibited act under section 3