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.

Quality Dairy Company, Lansing, MI
Ken Martin, president

In a May 13 warning letter the FDA described a Jan. 8- 17, 2020 inspection at Quality Dairy Company’s ready-to-eat sandwich, salad, and bakery products manufacturing facility. Inspectors found that the company had serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation.

FDA’s inspection resulted in the issuance of an FDA Form 483a. 

The significant violations are as follows:

Hazard Analysis and Risk-based Preventive Controls:

The firm produces 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. The firm’s sanitation control procedures did not ensure the cleanliness of food-contact surfaces and prevention of cross-contamination:

The directions for the sanitizer they use, (redacted), state that “(redacted)” and “(redacted).” However, their cleaning procedures conflict with the directions as follows:

The firm’s Commissary Cleaning of Stainless Tables procedure instructs employees to (redacted). Their commissary sanitation employee stated that after spraying the tabletops and other processing equipment with a sanitizer, he (redacted).

The firm’s Commissary Cleaning of Blue Deli Coolers procedure instructs employees to (redacted). Note that although the procedure is specifically for their commissary area, the coolers were being washed in the pan washroom.

iii. The firm’s Commissary Cleaning of Meat Slicer procedure instructs employees to (redacted). Further, they failed to follow their procedure to use a (redacted) before sanitizing the meat slicer. On January 9, 2020, FDA Investigator observed a commissary sanitation employee sanitize the meat slicer without first cleaning it with a (redacted).

The 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 (redacted) after sanitizer applied.” They did not indicate how they will ensure that employees follow their procedure to use a (redacted) before sanitizing the meat slicer. The FDA will verify the adequacy of the corrective actions and implementation during the next inspection.

The firm’s 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, the firm only had three area-specific cleaning and sanitation procedures of the (redacted) listed in the Master Cleaning Schedule: stainless tables, blue deli coolers, and meat slicer.

The 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 their response, it appears that they are working to establish and implement additional written SSOPs for the items listed on their master sanitation list. We will verify the adequacy of the corrective actions and implementation during the next inspection

The firm’s sanitation controls monitoring records were not reviewed within 7 working days after the records were created. Specifically, their sanitation preventive controls are monitored on a “Pre-Operation Check Sheet” and “Post Operation Schedule.” Review of these documents found as follows:

The firm’s 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.

The firm’s 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.

The firm’s response indicates that “all sanitation monitoring records will be reviewed daily and verified (redacted) by a PCQI (redacted) along with all documents associated with Preventative Controls.” However, their response did not include any documentation or completed records to show that this has been implemented. The FDA will verify the adequacy of the corrective actions and implementation during the next inspection.

They did not implement their written sanitation control verification procedures for environmental monitoring.

Their Environmental Monitoring procedure dated September 19, 2019, states that “(redacted) environmental sampling is to be taken from the production area” and is to be tested for mold, Listeria, and Salmonella. However, they did not take samples as frequently as required by their procedures. A review of their records found that they did not collect environmental samples from the commissary area for Listeria spp. between September 5, 2019, and November 7, 2019. Additionally, they did not collect environmental samples for Salmonella analysis from any area in their facility, including the bakery, since September 5, 2019.

The firm’s response includes an updated Environmental Monitoring procedure dated February 6, 2020, which states, “(redacted) environmental sampling is to be taken from the production area” to be tested for Listeria and Salmonella. The procedure provides for a minimum of (redacted) samples to be collected and identifies multiple sampling areas, including zone (redacted) (“Direct food contact areas/surfaces”). Their 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 the zone (redacted).

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 of collecting and testing samples. The timing and frequency for collecting and testing samples must be adequate to determine whether preventive controls are effective.

Include the corrective action procedures.

In addition, the firm’s corrective action procedures do not address the evaluation of all affected food for safety. Corrective action procedures must ensure that:

Appropriate action is taken to identify and correct a problem that has occurred with the implementation of preventive control.

Appropriate action is taken, when necessary, to reduce the likelihood that the problem will recur.

All affected food is evaluated for safety.

All affected food is prevented from entering into commerce if they cannot ensure that the affected food is not adulterated.

The FDA will verify the adequacy of their corrective actions during our next inspection.

Current Good Manufacturing Practice:

They failed to exclude pests from their food plant to protect against contamination of food. Specifically. The FDA investigators observed the following: 

On January 8, 2020, FDA 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.

On January 13, 2020, FDA 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, their pest control contractor has historically documented problems with German cockroaches. During the FDA pest control records review FDA found that, between May 16, 2019, and December 20, 2019, their pest control contractor left reports detailing the observation of approximately 47 German cockroaches. The German cockroaches documented by their pest control contractor were found in their entry area, dry storage area, in the bakery area along the donut production lines, and near their mixers.

Throughout the inspection, FDA investigators observed flying insects in their facility which were mostly concentrated along the donut lines. Since May 2019, their 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 the FDA’s previous inspection conducted from April 22, 2019- May 14, 2019. The firm’s response indicates that they have increased the frequency of their pest control service monitoring and installed additional light traps. However, no documentation was provided to verify either of these actions. The FDA will verify the adequacy of these corrective actions during their next inspection.

They did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination.

On January 9, 2020, in the commissary, an employee used a pressurized hose to rinse/spray cleaned production equipment and floors. The FDA observed overspray from spraying the floors being deposited on exposed cleaned and sanitized production equipment and utensils.

On January 8, 2020, an employee cleaning a donut icing flipper in the pan washroom 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 uses 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 the 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.

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.

The firm’s response indicates that its employees have been retrained and that sanitizing (redacted) is the last step in their updated cleaning procedures. Additionally, they have also obtained different color buckets for use when cleaning food contact surfaces and non-food contact surfaces. They have also clarified that the yellow buckets are for floor cleaning only. FDA 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 their facility. They 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 their responsibility to assure that they comply with all requirements of federal law and FDA regulations. They 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, the FDA offered the following comments:

During their inspection environmental swabs were collected from various locations throughout their processing areas. FDA laboratory analysis of the environmental sample INV1102223 collected on January 9, 2020, confirmed one swab positive for Listeria Seeliger, 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 Seeliger suggests that conditions also are suitable for survival and/or growth of Listeria monocytogenes, which has been found in their facility in the past.

Specifically, during the agency’s previous inspection of their facility in 2019, FDA laboratory analysis of the environmental sample INV1046680 collected on April 23, 2019, confirmed two swabs positive for Listeria monocytogenes. Furthermore, during an inspection conducted by MDARD in 2019, they confirmed seven swabs positive for Listeria monocytogenes, and in 2016 they confirmed one swab positive for Listeria monocytogenes. Whole-genome sequencing 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 their facility from 2016 to 2019. FDA advised them 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 their facility. The history of Listeria findings established by inspections conducted by the FDA and MDARD shows that ongoing attention needs to be paid to environmental monitoring and corrective actions to address Listeria’s findings and eliminate the organism from their environment.