- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameMr. Craig A. Friedman
Recipient TitleVice President
- Desserts by Helen, Inc.
283 Thompson Avenue
Louisville, KY 40206-1071
- Issuing Office:
- Division of Human and Animal Food Operations East V
Warning Letter 659181
September 11, 2023
Dear Mr. Friedman:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) bakery products manufacturing facility located at 283 Thompson Avenue, Louisville, KY 40206 from February 27 through March 13, 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).
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.
At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. FDA received your written response to the inspection via email on March 30, 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):
1. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable microorganisms) before starting work, after each absence from the workstation, and at any time when the hands may have become soiled or contaminated, as required by 21 CFR 117.10(b)(3). Specifically, the following employee practices were noted on February 28, 2023:
a. Two employees wearing gloves retrieved RTE chocolate cakes from the walk-in freezer. They touched the door handles, the interior surface of the walk-in freezer door, and plastic strip curtains that had a build-up of visible residue. The employees then touched the RTE chocolate cakes without washing and sanitizing their hands and changing their gloves. The employee then scooped chocolate sprinkles by hand, wearing the same gloves, and coated the cake with chocolate sprinkles.
b. During the manufacturing of RTE Mile High Chocolate Cake, an employee moved a trash can using their gloved hands, and then continued to apply chocolate sprinkles to the RTE cake without first washing and sanitizing their hands and changing their gloves.
Your March 30, 2023, response stated that “employees have been instructed on the importance of changing gloves and washing hands when there is danger of cross contamination. They have been instructed to wash their hands and change gloves whenever they touch an unsanitized surface, before touching food. This includes any operation that involves direct contact of food and other surfaces.” Additionally, you stated that “employees are now required to review and sign a compiled listing of GMP's for food safety and best practices that covers personal hygiene and cleanliness, disease control, proper clothing and jewelry restrictions, and personal behaviors required in a food manufacturing setting.” You also state that “both [the walk-in freezer ramp and strip curtain] areas are being attended to more often and kept clean.” However, your response does not specifically discuss sanitizing hands when they become contaminated. We will verify the effectiveness of your corrective actions during our next inspection.
2. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, on February 27 and 28, 2023 investigators observed the following conditions:
a. A metal storage shelf in the walk-in cooler was visibly unclean with a green and white substance, mold-like in appearance.
b. Apparent food residue and apparent green and white mold-like substance on a (b)(4) plastic pallet located in the walk-in cooler. The (b)(4) plastic pallet held a (b)(4) bucket of “(b)(4) WHOLE CHERRY FILLING.”
c. Standing brown liquid in the drainage basin located in the packaging room. The drainage basin also contained apparent dirt, concrete pieces, and pieces of cloth.
d. Pitted floors throughout the facility; they were visibly unclean and missing sealant in multiple areas. This is a repeat observation from FDA’s April 2022 inspection.
e. Unclean interior surfaces of the dishwashing machine with apparent mineral and food residue buildup. This is a repeat observation from FDA’s April 2022 inspection. Additionally, the water in the tank of the dishwashing machine was observed to contain food residue, that water is circulated and sprayed over the dishes as part of the wash/rinse process.
Your March 30, 2023, response stated that “more attention is being given to keeping equipment cleaner, including slicers, range top, depositors and other production equipment. Maintenance employees are being taught the proper standard of cleaning for all equipment.” You provided photographs of multiple pieces of cleaned equipment and surfaces throughout the facility. However, your response did not address the drainage issue or repairing the pitted floors. We will verify the effectiveness of your corrective actions during our next inspection.
3. You did not clean food contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against allergen cross-contact and against contamination of food, as required by 21 CFR § 117.35(d). Specifically, on February 28, 2023, FDA investigators observed the following conditions:
a. Employees used a metal scoop and spatula stored in the drawers of a (b)(4) toolbox that were visibly unclean with apparent food residue to apply icing to RTE Mile High Chocolate Cake without cleaning and sanitizing the utensils prior to use.
b. A buildup of food residue was observed on the interior sides and slicing blade of the cake slicer used to slice RTE Jalapeno Cornbread in the packaging room.
Your March 30, 2023, response stated that “more attention is being given to keeping equipment cleaner, including slicers, range top, (b)(4) and other production equipment. Maintenance employees are being taught the proper standard of cleaning for all equipment.” You provided photographs of multiple pieces of cleaned equipment and surfaces throughout the facility. We will verify the effectiveness of your corrective actions during our next inspection.
4. You did not clean non-food-contact surfaces of equipment in a manner and as frequently as necessary to protect against allergen cross-contact and contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Specifically, on February 28, 2023, FDA investigators observed the following conditions:
a. A buildup of food residue on the underside, spindle and rear splash guard of the stand mixers being used to manufacture RTE chocolate buttercream icing and Jalapeno Cornbread batter.
b. Food residue on the base, underside, locking lever and wheels of the batter dispensing machine located in the production room that was being used to manufacture RTE Jalapeno Cornbread batter.
c. Build-up of food residue on the top shelf extending over the stove, the stove’s backsplash, and the exhaust hood above the stove. An employee used the stove to melt margarine in a metal pot. This is a repeat observation from FDA’s April 2022 inspection.
d. Visibly unclean exteriors of various stand mixer bowls stored on metal shelving. An employee retrieved one such bowl and used it to manufacture Jalapeno Cornbread batter without cleaning and sanitizing the bowl prior to use.
Your March 30, 2023, response stated that “an additional employee has been added to do strictly cleaning,” so that you are “able to maintain the proper level of cleaning and housekeeping throughout the facility.” You then stated that this will allow you “to do more frequent deep cleans and maintain overall housekeeping.” Further you stated that employees “have also been instructed on the proper and sanitary handling of utensils and equipment.” You also stated that “more attention is being given to keeping equipment cleaner, including… range tops.” Lastly, you stated that “Employees have been retrained on the standard needed cleaning our mixers.” You provided photographs of multiple pieces of cleaned equipment and structural surfaces throughout the facility. We will verify the implementation and adequacy of these corrective actions during the next FDA inspection.
We note that your most recent response includes corrective actions that you previously promised to FDA on May 17, 2022, and September 13, 2022, in response to FDA’s April 2022 inspectional findings and as promised during the Regulatory Meeting held with your firm on October 7, 2022. Your 2022 responses stated that “more attention needs to be paid to our housekeeping and maintaining a stringent cleaning and maintenance schedule.” You also provided “a listing of the fixes made or being made” and photographs of multiple pieces of cleaned equipment and structural surfaces throughout the facility. However, during FDA’s most recent inspection, the investigators observed similar conditions, demonstrating that your corrective actions were inadequate and not sustainable.
5. Your plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR 117.20(b)(4). Specifically, an area of approximately 75 square feet located behind the walk-in freezer is not accessible for cleaning, as the space is too narrow for someone to access the area. The floors and walls are visibly unclean from apparent dirt and cobwebs. This is a repeat observation from FDA’s April 2022 inspection.
Your March 30, 2023, response did not address the cleaning of this area behind the walk-in freezer.
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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
In addition to the violations described above, we offer the following comments:
- During our inspection eighty (80) environmental swabs were collected from various locations throughout your processing areas. FDA laboratory analysis of environmental sample 1204755 collected on February 27, 2023, confirmed eleven (11) swabs positive for Listeria innocua and two (2) swabs positive for Listeria innocua/welshimeri, both non-pathogenic Listeria species. The positive findings include the drain in the basin of the packaging room where our investigator observed standing brown liquid, on the floor next to exterior door in the production room, and middle of the floor of the basin located in the packaging room. We note that the investigator observed floors that were pitted and visibly unclean throughout the facility and floors are potential sources of Listeria, especially where there are cracks and crevices. Furthermore, during our previous inspection in April 2022, FDA laboratory analysis of environmental sample 1171554 consisting of fifty (50) swabs collected on April 11, 2022, confirmed two (2) swabs positive for Listeria innocua, one (1) swab positive for Listeria ivanovii, and one (1) swab positive for Listeria grayi. The presence of Listeria species such as Listeria innocua, welchimeri, ivanovii, grayi suggests that conditions also are suitable for survival and/or growth of Listeria monocytogenes, an environmental pathogen. As a manufacturer of RTE bakery products, you are responsible to ensure that you have appropriate procedures and practices to prevent Listeria monocytogenes contamination in your facility.
- You must establish and maintain records that document your employees received training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties, as required by 21 CFR 117.4.
- Your facility meets the definition of a “qualified facility” under 21 CFR 117.3, therefore you are subject to the modified requirements in 21 CFR 117.201 of the CGMP & PC rule. These modified requirements include the requirement that the facility submit a form to FDA, attesting to the facility’s status as a qualified facility. In addition, you must attest that you have identified potential hazards associated with the food being produced, are implementing preventive controls to address hazards associated with the food being produced and are monitoring the performance of the preventive controls to ensure that such controls are effective; or your facility is in compliance with State, local, or other non-Federal food safety law. To date, you have not submitted an attestation.
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 actions within 15 working days, state the reason for the delay and the time within which you will do so. 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: Allison C. Hunter, Compliance Officer, via email at ORAHAFEAST5FirmResponses@fda.hhs.gov or at 550 Main Street, Suite 4-930, Cincinnati, Ohio 45202. You may also contact Allison Hunter at 513-322-0629 if you have any questions regarding this matter.
Steven B. Barber
Program Division Director
Office of Human and Animal Food Operations-East