- Delivery Method:
Recipient NameAngela Kakka
- Quick Foods Co.
711 E. 8 Mile Road
Ferndale, MI 48220
- Issuing Office:
- Chicago District Office
Chicago District Office
September 13, 2017
VIA UPS NEXT DAY
Angela Kakka, Owner
Quick Foods Co.
711 E. 8 Mile Road
Ferndale, MI 48220
Dear Ms. Kakka:
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 otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly your ready-to-eat tuna salad sandwiches are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Additionally, your turkey swiss sandwiches, corn beef swiss sandwiches, chicken and cheese sandwiches, ham and cheese Sandwiches, and Italian sandwiches are also adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S. C. § 342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. We acknowledge your undated response received by the Division on August 10, 2017, in response to the FDA 483, Inspectional Observations. Your response was not adequate, as further described in this letter.
You may find the Act, the seafood HACCP regulation and the CGMP regulation through links in FDA's home page at www.fda.gov.
Your significant deviations are as follows:
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.
Once a can or pouch of retorted tuna is opened and exposed to recontamination from the air, processing environment, and the inclusion of other ingredients during the making of the tuna salad product, pathogens and organisms responsible for scombrotoxin formation are reintroduced to the tuna meat, and given uncontrolled time-temperature conditions conducive to growth, the hazards are once again likely to occur. In addition, because your tuna salad is a ready-to-eat product, pathogen growth and toxin formation is a reasonably likely hazard that your firm needs to control with an effectively implemented written HACCP plan.
Your 483 response did not address this deviation.
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 immediately returning to handle ready to eat sandwiches without washing their hands.
According to your 483 response, you have begun reminding employees to wash their hands after touching insanitary objects. We will verify the adequacy of your corrective actions during our next inspection.
3. Employees must confine eating in areas other than where food is exposed and equipment or utensils are washed, to comply with 21 CFR 110.10(b)(8). However, an employee was observed eating cheese in the production room while handling finished ready to eat sandwiches.
Your 483 response indicates you have advised your employees that eating during production is prohibited. We will verify the adequacy of your corrective action during our next inspection.
4. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food, to comply with 21 CFR 110.35(d). However, an employee was repeatedly observed using a knife to open cardboard boxes of deli meat and then immediately using the knife to cut through the plastic packaging of the meat. The knife was observed contacting the ready to eat meat.
Your 483 response indicates you have purchased dedicated box openers to avoid the usage of processing knives for opening boxes. We will verify your implementation of this corrective action during our next inspection.
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.
Your 483 response indicates you will ensure the proper drain pipe installation (b)(4). However, you did not address your current facility (b)(4).
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.
In response to the FDA 438, you indicate you (b)(4) and the temperature will be easier to manage. However, your response did not indicate (b)(4) how the temperature will be more easily managed. Your response also indicates you will send your delivery trucks to a facility that will ensure all trucks are 37 ºF. We will verify the adequacy of your corrective actions during our next inspection.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps that you are taking to correct these violations. You should include in your response documentation such as monitoring and data logger records, HACCP plan revisions, photographs of the facility, sanitization logs, and any other information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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.
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 from the responsible party of the domestic facility. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the 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 re-inspection-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 Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be addressed to:
Lauren Crivellone, Compliance Officer
FDA Chicago District Office
U.S. Food and Drug Administration
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Refer to the Unique Identification Number (CMS Case #167847) when replying. If you have any questions about the content of this letter, please contact Ms. Crivellone via email at email@example.com or by phone at (312)-596-4157.
William R. Weissinger, MS
Chicago District Director
Division of Human and Animal Food
Operations Division 6 East