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.

Gary’s Cheesecakes & Fine Desserts
Cincinnati, OH

A company in Ohio is on notice from the FDA for serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, including the presence of a dead rodent and rodent excreta in the facility.

In an April 28, 2023, warning letter, the FDA described a Jan. 31 through Feb. 15, 2023, inspection of Gary’s Cheesecakes & Fine Desserts’ ready-to-eat (RTE) bakery products manufacturing facility in Cincinnati, OH.

At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at their facility.

Some of the significant violations are as follows:

Current Good Manufacturing Practice:
The firm did not take effective measures to exclude pests from their food manufacturing plant to protect against contamination of food, as required. Specifically, the following conditions were observed:

  • On Jan. 31, 2023, an apparent dead rodent, attached to a glue trap inside of an open cardboard box, located next to the standing mixer.
  • On Jan. 31, 2023, approximately 10 apparent rodent excreta pellets with a black, shiny, and soft appearance inside of a junction between preparation tables where RTE brownies were being iced.
  • On Jan. 31, 2023, apparent rodent excreta pellets with a black, shiny, and soft appearance, too numerous to count, between ingredient bags and directly below a storage rack used to store bulk dry ingredients.
  • On Jan. 31, 2023, apparent insect activity on a glue trap next to a (redacted) with an approximately one-inch gap.
  • On Feb. 8, 2023, multiple apparent dead insects attached to two glue traps, adjacent to the (redacted) oven. In addition, a section of the glue trap was torn, which they stated was due to a mouse that chewed through the glue trap to escape when it was caught on the trap.
  • On Feb. 13, 2023, apparent rodent excreta pellets with a black, dull, and hard appearance, too numerous to count, inside an enclosed shelf under the (redacted) behind boxes containing icing piping bags and on a sheet pan used to store RTE brownies prior to slicing.

This is a repeat observation from FDA’s 2020 inspection, as apparent rodent excrement was observed on and around an in-use caramel container used as a topping on RTE desserts, and on a shelf directly below where plates for the slicing machine are stored.

The firm’s March 7, 2023 response stated that they disposed of glue traps with captured pests, placed new glue traps, removed rodent excreta pellets, cleaned and sanitized areas where rodent excreta pellets were found, added cleaning tasks to their (redacted) sanitization schedule, and will schedule garage door maintenance. However, their response does not show that the corrective actions are being implemented on a continual basis, and that they are effectively excluding pests from the facility. Additionally, they did not provide evidence of the scheduled garage maintenance, such as a maintenance request or work order.

The FDA notes that their most recent response includes corrective actions that they previously submitted to FDA on March 8, 2020, in response to FDA’s 2020 inspectional findings. As corrective action to the rodent excrement, the firm’s 2020 response stated that they cleaned and sanitized areas exposed to rodent excrement and placed new glue traps. However, during FDA’s most recent inspection, the investigators observed similar conditions, demonstrating that their corrective actions were inadequate and pest activity continues to persist in their facility. Additionally, during the most recent inspection, the FDA investigator discussed using a professional pest control service, they stated that they would contact a professional pest control company to inquire about servicing the facility; however, their response did not mention acquiring professional pest control services.

Failure to Register Food Facility:
In addition, FDA has determined that their facility in Cincinnati, OH, 45238 is subject to the food facility registration requirement, and FDA  implementing of the Act requires facilities that are required to register with the FDA to renew their registrations every other year during the period beginning on Oct. 1 and ending on Dec. 31 of each even-numbered year. (Redacted). Failure to register a facility as required is prohibited.

The full warning letter can be viewed here.

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