FDA found two positive Listeria monocytogenes samples in the processing area - one from a wheel of (?) that was supported by a stack of lids located in the back kitchen. The lids contained accumulated water and debris and were continuously leaking product at connection junctions. And another positive sample from under the packer [equipment?] in the back kitchen. Potato salad was being manufactured in the back kitchen during the inspection.
The WGS analysis found two different strains of LM, and both of these strains had been found in the company's other processing facility during a previous year's sampling. Because of this, FDA deemed that the plant did not have adequate control of Listeria.
- One of the strains of LM found was genetically identical to isolate found in thier other processing facility. "that it is identical to (b)(4) FDA environmental swabs collected from your Chester, SC facility in May 2012, August 2013, and April 2015. This strain was also found in (b)(4) isolates that were obtained from USDA samples of chicken salad and ham salad from your Charlotte, NC facility, and (b)(4) of USDA’s environmental swabs collected from your Charlotte, NC facility in 2015."
- The other strain of L. monocytogenes "shows that it is identical to L. monocytogenes isolated from FDA’s February 2017 sample of your Chester, SC facility’s pimento spread, the state of North Carolina’s 2017 sample of your pimento cheese and old fashioned spread, and FDA environmental swabs collected from your Chester, SC facility in May 2012, August 2013 and April 2015. This evidence demonstrates that L. monocytogenes had maintained a presence in your Chester, South Carolina facility from 2012-2017 and an identical strain of L. monocytogenes has been isolated in your Charlotte, NC processing environment."
The facility was sited with numerous GMP violations.
- The production sprayers and the water bath hose were observed pooling water throughout the entire production room floor and splashing water onto food contact surfaces
- Soiled garments of employees including hair nets, arm guards, and aprons coming into direct contact with raw ingredients and in-process finished product.
- An employee was observed using a probe thermometer to check the temperature of each batch of pimento spread without cleaning or sanitizing it between uses.
- Employees storing and resting food contact equipment such as product scoops and spatulas on non-food contact surfaces such as brown paper towels and tables then using them to manipulate raw materials and/or in process finished product without first washing or sanitizing them.
- After sanitation operations, had been completed in the back kitchen a mixer had chicken salad residue and dried mayo debris on the paddle, the interior and the mixer stand attachment. The equipment was used for the next production run without any additional sanitation being performed
- A bucket labeled as sweet pickle relish to contain bleach, a bucket labeled as diced celery to contain quaternary ammonia, and an unidentified container, which reportedly contained bleach, was found to contain a 50ppm chlorine solution.
- Chemicals were observed to be stored directly adjacent to the potato washer and the potato conveyor where food items were actively undergoing processing. In addition, the investigators observed sanitizer overspray to be inside an open box containing finished product containers as well as wetting boxes containing finished product container.
- Finished product troughs, raw ingredient transport bowls, and mixers were observed to be pitted and cracked, cutting boards contained numerous gauges and cuts and salad tubs were heavily gouged.
- Two pallets of canned pimentos and one pallet of canned jalapenos were observed to be stored in the maintenance shop. The pallet of jalapenos had opened motor oil containers and lubricants stored on top. The front pallet of pimento had a viscous black liquid spilled onto the middle cans on the pallet. Chemical drums stored adjacent to the rear kitchen were observed to be leaking onto open boxes of finished product containers
- Condensate was observed dripping onto packaged product, exposed raw materials such as relish and cabbage, and food contact surfaces. Condensate was also observed pooling where sanitized production equipment was being stored.
- Accumulated condensation from a shop fan in the front and was blowing onto sanitized cooked potato containers.
- An employee in the front kitchen was observed using gloved hands to assemble sanitized production equipment. This employee stopped assembly to manipulate the hose that had been on the floor and then resumed assembling the sanitized equipment without first washing and sanitizing or changing the gloves.
- Multiple employees were observed returning from breaks without washing their hands or washed their hands and then put on hairnets and earphones, without first re-washing their hands, before resuming production activities in the front and back kitchens and the spice room.
- The equipment washing sink in the front kitchen was observed to be directly plumbed into the sewer system without an air break or a backflow prevention device.
FDA Warning Letter
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm586088.htm
November 14, 2017
WARNING LETTER
18-ATL-01
Stanley C. Bracey, President
Bill R. Rudisill, General Manager
B&H Foods
2122 Thrift Road
Charlotte, NC 28208
Dear Mr. Bracey:
The United States Food & Drug Administration (FDA) inspected your refrigerated ready-to-eat (RTE) salad manufacturing facility located at 2122 Thrift Road, Charlotte, NC 28208 from May 9 through 31, 2017. During our inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility, including areas that are near food and food contact surfaces. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110) [1]. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we have determined that your RTE food products 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 been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.