- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameGary W. Haas
- Gary’s Cheesecakes & Fine Desserts
5285 Crookshank Road
Cincinnati, OH 45238-3364
- Issuing Office:
- Division of Human and Animal Food Operations East V
WARNING LETTER 654471
April 28, 2023
Dear Mr. Haas:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery products manufacturing facility located at 5285 Crookshank Road, Cincinnati, Ohio 45238, on January 31 through February 15, 2023. During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 Part CFR 117). At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the RTE bakery products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and FDA regulations through links in FDA's home page at http://www.fda.gov.
FDA received your written response via email on March 7, 2023, describing the corrective actions you have taken and plan to take. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We also address your response below.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
You did not take effective measures to exclude pests from your food manufacturing plant to protect against contamination of food, as required by 21 CFR § 117.35(c). Specifically, the following conditions were observed:
- On January 31, 2023, an apparent dead rodent, attached to a glue trap inside of an open cardboard box, located next to the standing mixer.
- On January 31, 2023, approximately ten 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 January 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 January 31, 2023, apparent insect activity on a glue trap next to a (b)(4) with an approximately one-inch gap.
- On February 8, 2023, multiple apparent dead insects attached to two glue traps, adjacent to the (b)(4) oven. In addition, a section of the glue trap was torn, which you stated was due to a mouse that chewed through the glue trap to escape when it was caught on the trap.
- On February 13, 2023, apparent rodent excreta pellets with a black, dull, and hard appearance, too numerous to count, inside an enclosed shelf under the (b)(4) 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.
Your March 7, 2023 response stated that you 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 your (b)(4) sanitization schedule, and will schedule garage door maintenance. However, your response does not show that the corrective actions are being implemented on a continual basis, and that they are effectively excluding pests from your facility. Additionally, you did not provide evidence of the scheduled garage maintenance, such as a maintenance request or work order.
We note that your most recent response includes corrective actions that you previously submitted to FDA on March 8, 2020, in response to FDA’s 2020 inspectional findings. As corrective action to the rodent excrement, your 2020 response stated that you 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 your corrective actions were inadequate and pest activity continues to persist in your facility. Additionally, during the most recent inspection, the FDA investigator discussed with you using a professional pest control service, you stated that you would contact a professional pest control company to inquire about servicing your facility; however, your response did not mention acquiring professional pest control services.
Failure to Register Food Facility:
In addition, FDA has determined that your facility at 5285 Crookshank Road, Cincinnati, Ohio 45238 is subject to the food facility registration requirement in section 415 of the Act [21 U.S.C. § 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. Section § 415(a)(3) of the Act requires facilities that are required to register with FDA to renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. (b)(3). Failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)].
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to adequately address this matter may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Christopher N. Dedeaux, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 404 BNA Drive, Suite 500, Nashville, TN 37217. You may also reach Christopher Dedeaux at 504-846-6122 or if you have any questions regarding this matter.
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East