- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameMr. Ken Martin
- Quality Dairy Company
1335 Diamond Reo Way
Lansing, MI 48910-1464
- Issuing Office:
- Division of Human and Animal Food Operations East VI
May 13, 2020
Dear Mr. Martin:
The U.S. Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) sandwich, salad and bakery products manufacturing facility located at 1335 Diamond Reo Way, from January 8, 2020, through January 17, 2020. During our inspection of your facility, FDA investigators 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 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations.
Based on FDA’s inspectional findings, we have determined that the RTE sandwiches, salads and bakery products manufactured at 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 whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links in FDA's Internet home page at http://www.fda.gov.
We received your written response dated February 19, 2020, describing corrective actions taken and planned by your firm. 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.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You produce RTE foods exposed to the environment and thus apply sanitation controls to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergens. Your sanitation control procedures did not ensure cleanliness of food-contact surfaces and prevention of cross-contamination, as required by 21 CFR 117.135(c)(3).
a. The directions for the sanitizer you use, (b)(4), state that “(b)(4)” and “(b)(4).” However, your cleaning procedures conflict with the directions as follows:
i. Your Commissary Cleaning of Stainless Tables procedure instructs employees to (b)(4). Further, your commissary sanitation employee stated that after spraying the tabletops and other processing equipment with sanitizer, he (b)(4).
ii. Your Commissary Cleaning of Blue Deli Coolers procedure instructs employees to (b)(4). Note that although the procedure is specifically for your commissary area, the coolers were being washed in the pan wash room.
iii. Your Commissary Cleaning of Meat Slicer procedure instructs employees to (b)(4). Further, you failed to follow your procedure to use a (b)(4) before sanitizing the meat slicer. Specifically, on January 9, 2020, our Investigator observed a commissary sanitation employee sanitize the meat slicer without first cleaning it with a (b)(4).
Your firm’s response indicates that “All SSOP’s have been updated to reflect correct procedures and follow the chemical manufacturer’s direction for use. Each revised SSOP instructs (b)(4) after sanitizer applied.” You did not indicate how you will ensure that employees follow your procedure to use a (b)(4) before sanitizing the meat slicer. We will verify adequacy of the corrective actions and implementation during the next inspection.
b. Your Cleaning and Sanitation procedures (revision date 3/14/2015) state that “SSOPs for each item covered under the Master Cleaning Schedule” “will be documented and stored at the supervisor’s station and made available.” However, you only had three area-specific cleaning and sanitation procedures of the (b)(4) listed in the Master Cleaning Schedule: stainless tables, blue deli coolers, and meat slicer.
Your firm’s response indicates that, “The Post-Op Daily Sanitation Sheet has been updated. The area-specific cleaning and sanitation procedures have been updated and expanded to show all procedures.” In your response it appears that you are working to establish and implement additional written SSOPs for the items listed on your master sanitation list. We will verify adequacy of the corrective actions and implementation during the next inspection.
2. Your sanitation controls monitoring records were not reviewed within 7 working days after the records were created, as required by 21 CFR 117.165(a)(4). Specifically, your sanitation preventive controls are monitored on a “Pre-Operation Check Sheet” and “Post Operation Schedule.” Review of these documents found as follows:
a. Your Pre-Operation Check Sheets were not reviewed for the following dates: 7/16/19, 8/23/19, 9/18/19, 11/1/19, 11/27/19, and 12/12/19.
b. Your Quality Dairy Commissary Post Operation Schedules were not reviewed for the following date ranges: 10/28/19-11/1/19, 11/25/19-11/27/19, and 12/09/19-12/13/19.
Your firm’s response indicates that “all sanitation monitoring records will be reviewed daily and verified (b)(4) by a PCQI (b)(4) along with all documents associated with Preventative Controls.” However, your response did not include any documentation or completed records to show that this has been implemented. We will verify adequacy of the corrective actions and implementation during the next inspection.
3. You did not implement your written sanitation control verification procedures for environmental monitoring, as required by 21 CFR 117.165(b).
Your Environmental Monitoring procedure dated September 19, 2019, states that “(b)(4) environmental sampling is to be taken from the production area” and is to be tested for mold, Listeria, and Salmonella. However, you did not take samples as frequently as required by your procedures. Specifically, review of your records found that you did not collect environmental samples from the commissary area for Listeria spp. between September 5, 2019, and November 7, 2019. Additionally, you did not collect environmental samples for Salmonella analysis from any area in your facility, including the bakery, since September 5, 2019.
Your firm’s response includes an updated Environmental Monitoring procedure dated February 6, 2020, which states, “(b)(4) environmental sampling is to be taken from the production area” to be tested for Listeria and Salmonella. The procedure provides for a minimum of (b)(4) samples to be collected and identifies multiple sampling areas, including zone (b)(4) (“Direct food contact areas/surfaces”). Your response includes one set of environmental monitoring records with a laboratory analysis report dated February 17, 2020. The report indicates that no swabs were collected from zone (b)(4).
Please be aware that, as required by 21 CFR 117.165(b)(3), procedures for environmental monitoring must, among other requirements:
• Identify the locations from which samples will be collected and the number of sites to be tested during routine environmental monitoring. The number and location of sampling sites must be adequate to determine whether preventive controls are effective;
• Identify the timing and frequency for collecting and testing samples. The timing and frequency for collecting and testing samples must be adequate to determine whether preventive controls are effective; and
• Include the corrective action procedures required by 21 CFR 117.150(a)(1).
In addition, your firm’s corrective action procedures do not address the evaluation of all affected food for safety. Note that corrective action procedures must, as required by 21 CFR 117.150(a)(2), ensure that:
• Appropriate action is taken to identify and correct a problem that has occurred with implementation of a preventive control;
• Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur;
• All affected food is evaluated for safety; and
• All affected food is prevented from entering into commerce, if you cannot ensure that the affected food is not adulterated.
We will verify the adequacy of your corrective actions during our next inspection.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You failed to exclude pests from your food plant to protect against contamination of food as required by 21 CFR 117.35(c). Specifically. our investigators observed the following:
a. On January 8, 2020, our investigators observed five apparent dead German cockroaches: one in the “candy room,” three in the dry storage area approximately six feet away from blue and white sprinkles, and one in the bakery area; one apparent live German cockroach nymph on the wall in the bakery area adjacent to the yeast donut line approximately 12 feet away; apparent rodent excreta pellets in the boiler room; and an apparent dead mouse in the boiler room.
b. On January 13, 2020, our investigators observed one apparent live German cockroach nymph crawling on the MDARD Inspector’s white inspection coat. The apparent German cockroach nymph was discovered on her inspection coat immediately after she examined the dry-cleaning process on the yeast donut line. Furthermore, your pest control contractor has historically documented problems with German cockroaches. During our pest control records review we found that, between May 16, 2019 and December 20, 2019, your pest control contractor left reports detailing the observation of approximately 47 German cockroaches. The German cockroaches documented by your pest control contractor were found in your entry area, dry storage area, in the bakery area along the donut production lines, and near your mixers.
c. Throughout the inspection, our investigators observed flying insects in your facility which were most concentrated along the donut lines. Since May 2019, your pest control contractor has documented multiple observations of aquatic flies, gnats, house flies, fruit flies, blow/bottle flies, and green bottle flies.
Pest observations were also documented during FDA’s previous inspection conducted from April 22, 2019- May 14, 2019. Your firm’s response indicates that you have increased the frequency of your pest control service monitoring and installed additional light traps. However, no documentation was provided to verify either of these actions. We will verify the adequacy of these corrective actions during our next inspection.
2. You did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination, as required by 21 CFR 117.80(c)(6). Specifically,
a. On January 9, 2020, in the commissary, an employee used a pressurized hose to rinse/spray cleaned production equipment and floors. We observed overspray from spraying the floors being deposited on exposed cleaned and sanitized production equipment and utensils.
b. On January 8, 2020, an employee cleaning a donut icing flipper in the pan wash room broke down the icing flipper into three parts and cleaned and sanitized each one separately. After cleaning and sanitizing the main housing of the icing flipper, the employee use a pressurized hose to spray the two removable pieces. The water from the pressurized hose was observed coming into contact with the floor and landing on the cleaned and sanitized icing flipper. The employee re-sanitized the icing flipper after installing the first removable piece, but water was again observed hitting the floor and landing on the icing flipper when the second removable piece was sprayed with water. The employee did not re-sanitize the entire icing flipper after installing the last piece.
c. On January 13, 2020, a sanitation employee scrubbed the donut cooling conveyor, a food contact surface, with a brush that was stored in a yellow bucket with water. This bucket is the same shape, color, and style with the same markings as the yellow buckets used to mop the floors around the facility.
Your firm’s response indicates that your employees have been retrained and that sanitizing ((b)(4)) is the last step in your updated cleaning procedures. Additionally, you have also obtained different color buckets for use when cleaning food contact surfaces and non-food contact surfaces. You have also clarified that the yellow buckets are for floor cleaning only. We will verify the adequacy of the implementation of these corrective actions during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the cause of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
In addition to the violations described above, we offer the following comments:
During our inspection environmental swabs were collected from various locations throughout your processing areas. FDA laboratory analysis of the environmental sample INV1102223 collected on January 9, 2020, confirmed one (1) swab positive for Listeria seeligeri, a non-pathogenic Listeria species. This positive swab was collected from a food contact surface area on a small hole on a stainless-steel table used to assemble sub sandwiches. The presence of Listeria species such as Listeria seeligeri suggests that conditions also are suitable for survival and/or growth of Listeria monocytogenes, which has been found in your facility in the past.
Specifically, during the agency’s previous inspection of your facility in 2019, FDA laboratory analysis of the environmental sample INV1046680 collected on April 23, 2019, confirmed two (2) swabs positive for Listeria monocytogenes. Furthermore, during an inspection conducted by MDARD in 2019, they confirmed seven (7) swabs positive for Listeria monocytogenes and in 2016 they confirmed one (1) swab positive for Listeria monocytogenes. Whole genome sequencing (WGS) of the Listeria monocytogenes isolates found that the 2 isolates from FDA 2019 sample and 1 isolate from MDARD 2019 sample are genetically identical. Additionally, the remaining 6 isolates from the MDARD 2019 sample and 1 isolate from the MDARD 2016 sample were determined to be genetically identical, indicating the presence of a resident pathogen in your facility from 2016 to 2019. We advised you of the WGS analysis during our Regulatory Meeting held on September 4, 2019.
When positive findings are confirmed it is critical that corrective actions are established and implemented to address any positive findings in order to eliminate the organism from your facility. The history of Listeria findings established by inspections conducted by FDA and MDARD shows that ongoing attention needs to be paid to environmental monitoring and corrective actions to address Listeria findings and eliminate the organism from your environment.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31 (a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
You should respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your firm’s response should be sent to Kathryn Cutajar, Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions about this letter, please contact Kathryn Cutajar at (313) 393-8250 or via email Kathryn.Cutajar@fda.hhs.gov.
William R. Weissinger, MS
Chicago District Director
Office of Human and Animal Food Operations
Division East 6
John Lake, Plant Manager
Quality Dairy Company
1335 Diamond Reo Way
Lansing, MI 48910-1464