Is Quick Foods Co. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

5.    Your plumbing must have backflow protection from piping systems that discharge waste water, to comply with 21 CFR 110.37(b)(5). However, no backflow prevention devices were observed on the drain pipes leading from the three-compartment sink.

6.    You must hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated, to comply with 21 CFR 110.80(b)(3)(i). However, on multiple days of the inspection, your walk in cooler temperature ranged from 45ºF to 59.7ºF. During this time, the cooler contained a variety of raw ingredients and ready-to-eat sandwiches. In addition, your delivery trucks, which are used to transport sandwiches up to an hour away, were found with temperature readings ranging from 46.8 ºF to 70.3ºF. These temperatures are conducive to the growth of pathogenic microorganisms.

This letter may not list all the violations at your facility. 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 processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), and the current good manufacturing regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Potential Health Risks

The U.S. Food and Drug Administration (FDA) inspected your seafood and ready to eat sandwich processing facility, located at 711 E. 8 Miles Road, Ferndale, MI on July 6, 2017 through July 19, 2017. During that inspection, we found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 and the Current Good Manufacturing Practices (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110. At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm. In accordance with 21 CFR 123.6 (b), failure of a processor of fish or fishery products to implement a HACCP plan that complies with this section or o

Regulatory Context

You may find the Act, the seafood HACCP regulation and the CGMP regulation through links in FDA's home page atwww.fda.gov.

1.    You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for tuna salad sandwiches does not list the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation.

2.    Employees must wash hands thoroughly in an adequate hand-washing facility after their hands may have become soiled, to comply with 21 CFR 110.10(b)(3). However, during the current inspection, employees were observed touching ready-to-eat sandwiches immediately after touching product labels that had been dragged on the floor without first washing their hands. The floor may have been contaminated with raw chicken juices that were observed leaking in the cooler and spread through the production area by worker’s shoes. Production employees were also observed touching the cooler handle door and light switch, then immediately returning to assemble ready to eat sandwiches without washing their hands. One employee was also observed scratching their eye and ear with their hands and immediatel