"According to the complaint filed with the consent decree, the FDA inspected the facility seven times between May 2009 and June 2018. During each inspection, the FDA investigators observed significant objectionable conditions. The FDA also found L. mono in the facility in two of the inspections, including the most recent inspection. The company was issued an FDA Form 483 after each of the seven inspections, was issued a warning letter in April 2016 and the company attended a regulatory meeting with the FDA in January 2017. The defendants repeatedly promised to take corrective actions to address the objectionable conditions. However, the FDA’s June 2018 inspection showed that the defendants have failed to take effective measures to bring Home Style Foods’ ready-to-eat food processing operations into compliance with the law."
FDA News Release
https://www.fda.gov/news-events/press-announcements/michigan-based-food-manufacturer-agrees-stop-production-after-repeated-food-safety-violations
Michigan-based food manufacturer agrees to stop production after repeated food safety violations
For Immediate Release:January 13, 2020
Today, U.S. District Judge Sean F. Cox entered a consent decree of permanent injunction between the U.S. and Home Style Foods, Inc., and the company’s owner, Michael J. Kowalski, and quality manager, Juan Valesquez. Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the U.S. Food and Drug Administration, which found Listeria monocytogenes (L. mono) in the company’s food preparation area and violations of seafood safety regulations associated with the processing of fish and fishery products.
“After repeated food safety violations, the FDA worked with the U.S. Department of Justice to obtain this injunction in order to prevent potentially contaminated food from reaching consumers. The company failed to take the appropriate corrective actions resulting in this action,” said FDA Chief Counsel Stacy Cline Amin, J.D. “When a company fails to follow the law, the government will take action to protect the food supply.”
The consent decree prohibits the defendants from receiving, preparing, processing, packing, holding, labeling and/or distributing foods at or from their facility, or any other facility, until certain requirements are met. The consent decree requires the defendants to make corrective actions and notify the FDA before operations may resume.
L. mono is a species of disease-causing bacteria. When people eat food contaminated with L. mono., they may develop a disease called listeriosis. This infection can have serious adverse effects for consumers, particularly women who are or may become pregnant, the elderly and people with weakened immune systems.
According to the complaint filed with the consent decree, the FDA inspected the facility seven times between May 2009 and June 2018. During each inspection, the FDA investigators observed significant objectionable conditions. The FDA also found L. mono in the facility in two of the inspections, including the most recent inspection. The company was issued an FDA Form 483 after each of the seven inspections, was issued a warning letter in April 2016 and the company attended a regulatory meeting with the FDA in January 2017. The defendants repeatedly promised to take corrective actions to address the objectionable conditions. However, the FDA’s June 2018 inspection showed that the defendants have failed to take effective measures to bring Home Style Foods’ ready-to-eat food processing operations into compliance with the law.
The complaint was filed by the U.S. Department of Justice on behalf of the FDA.
The FDA is not aware of any confirmed illnesses related to these products. However, consumers who think they may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report problems with any FDA-regulated products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The FDA is not aware of any confirmed illnesses related to these products. However, consumers who think they may have been sickened by these products should seek the assistance of a health care professional and contact the FDA to report problems with any FDA-regulated products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/home-style-foods-inc-04262016
Home Style Foods, Inc.
April 26, 2016
Mr. Michael J. Kowalski, President
Home Style Foods, Inc.
5163 Edwin Street
Hamtramck, MI 48212
Dear Mr. Kowalski:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat seafood and deli salad manufacturing facility located at 5163 Edwin St., Hamtramck, MI, on September 15 through October 19, 2015. This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. During the inspection, FDA collected environmental samples (swabs) from various areas in your processing facility, including areas that are in close proximity to food and food contact surfaces. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human foodborne pathogen,in your ready-to-eat seafood and deli salad production room.FDA laboratory analyses also confirmed the presence of Listeria welshimeri and Listeria innocua in the production room. During our inspection, FDA investigators observed violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR part 110).
Furthermore, 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 (21 CFR part 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and 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 withi the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §342(a)(4).
Based on FDA’s analytical results for the environmental sampling, inspectional findings documented during the inspection, and serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, we determined that your ready-to-eat seafood salad and deli salad products are adulterated within the meaning of section 402(a)(4) of the Act, 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 www.fda.gov.
We acknowledge your firm’s November 2, 2015, response to the FDA-483, which includes a description of corrections to the observations noted on the FDA-483. However, your response cannot be evaluated because it does not provide sufficient information about the adequacy of your corrective actions in addressing the violations observed during the inspection.
Presence of Listeria
FDA laboratory analysis of the environmental samples collected from various locations at your firm’s processing facility on September 15 and 16, 2015, confirmed that four (4) of the sixty-three (63) environmental swabs were positive for Listeria spp., including one positive for L. monocytogenes. The positive L. monocytogenes swab was taken from the wheels of a pallet jack that is pulled throughout the entire facility including the warehouse, finished product cooler, and the ready-to-eat salad production room, where the pallet jack was located during the sampling procedure, and was observed to be surrounded by standing water. This swab of the pallet jack also tested positive for L. welshimeri.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take corrective actions to eradicate the organism by rendering these areas unable to support the growth and survival of the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening, illness called listeriosis, an atypical foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect older adults, pregnant women, newborns, and adults with weakened immune systems.
FDA investigators collected swab samples from the floor drain located in your production room between lines (b)(4) and a swab from water droplets present on a cover/guard of a ready-to-eat (RTE) salads mixer. Both tested positive for L. welshimeri. Additionally, a swab in the production room from the wheels of a tote that is used to hold bulk salads tested positive for both L. welshimeri and L. innocua, which are non-pathogenic species of the genus Listeria. The presence of Listeria species such as L. innocua and L. welshimeri suggests that conditions also are suitable for survival and/or growth of L. monocytogenes. Thus, the presence of these indicator organisms is significant in that it further demonstrates inadequate sanitation practices within your facility, and manufacturing conditions that may reasonably allow for contamination of food.
Current Good Manufacturing Practice (CGMP)
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods (21 CFR part 110):
1. Your firm failed to maintain general building, fixtures, and other physical facilities of the plant in a sanitary condition and in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. Additionally, you did not ensure cleaning and sanitizing of utensils and equipment were conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically:
a. An employee was observed using a hose to spray off cleaner from food processing equipment on Line (b)(4), a process which caused aerosolized water to contact the food contact surfaces of a hopper, mixer, mixer cover/guard, and exposed bag-in-box packaging that was waiting to be filled with RTE potato salad. As described above, a swab sample taken by FDA investigators of the water droplets on the mixer cover/guard tested positive for L. welshimeri.
b. An employee was observed using a hose to spray the floor and equipment between and around Lines (b)(4) and (b)(4), a process which caused aerosolized water droplets to spray on bags of mayonnaise in cases which were staged for use in the production of RTE coleslaw, and on exposed packaging materials that were waiting to be filled with coleslaw on the packaging conveyor line. As described above, a sample collected from the floor drain located between Lines (b)(4) tested positive for L. welshimeri. Additionally, during the inspection a spray hose was observed on the floor within approximately 18 inches of this drain. Employees were observed using the spray hose and routinely touching the surfaces of the hose and processing equipment indiscriminately.
c. An employee was observed using a hose to spray the floor and equipment on Line (b)(4), causing aerosolized droplets to transfer from the floor to food contact surfaces of the mixer and mixer cover guard on Line (b)(4), on which RTE foods are processed.
Seafood HACCP
Your significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP regulation, 21 CFR Part 123 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 seafood salads does not list the food safety hazards of undeclared allergens and Clostridium botulinum growth and toxin formation.
a. For the hazard of undeclared allergens, your salads include the ingredients finfish, shellfish, wheat, egg, soy and milk, which are identified by FDA as major food allergens. FDA recommends that firms include controls in their HACCP plans to ensure that all finished product labeling accurately lists all major food allergens that are included in the product.
b. Your salads are packaged as 10 pounds in a bag inside a box, which may introduce the hazard of Clostridium botulinum. Packaging materials with low oxygen transmission rates (OTR) are considered by FDA to be reduced oxygen packaging because they significantly limit oxygen transmission between the product and the surrounding air. For control of the C. botulinum hazard, in addition to a finished product storage critical control point (CCP) with a critical limit of 40°F or below, FDA recommends that your products have a secondary barrier, such as formulating the products to have a water activity below 0.97, or a pH of 5.0 or below, with a corresponding CCP in your HACCP plan. Alternatively, if you choose not to include controls for water activity or pH in your plan, your firm has the option of affixing time/temperature integrators (TTIs) to the individual salad containers, along with maintaining your storage temperatures at or below 38°F. TTIs enable end users to determine if the packages have been exposed to times and temperatures that can lead to the C. botulinum germination, growth and toxin formation. Or, you may opt to use final product packaging that has a minimum OTR of 10,000 cc/m2/24 hours.
2. You must list appropriate monitoring procedures in your HACCP plan, to comply with 21 CFR 123.6 (c)(4). However, your HACCP plan fails to list an adequate monitoring procedure at the refrigerated storage critical control points to control the hazards of pathogens and histamine listed in your HACCP plan for your seafood salads. Your firm’s response letter dated November 2, 2015 states that you are using a data recording device to continuously track and record cooler temperatures, and that the (b)(4) are then reviewed (b)(4). In addition to (b)(4) reviews, FDA recommends that a check of the recorded data be conducted on a daily basis as a monitoring procedure, so that any temperature excursions are identified promptly. Verification reviews of the recorded data with daily checks may be conducted on a weekly basis.
The above violations are not meant to be an all-inclusive list of violations that may exist at your facility or with respect to your products. It is your responsibility to ensure that your facility and your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to implement procedures to prevent such violations from recurring. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Labeling Comments
1. If you choose to use a Contains statement in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), the statement must declare the common or usual name of all major food allergens intentionally added to the product. In the case of fish, the common or usual name of the fish species must be declared. Your Sub-Tuna Salad, Key West Rotini, Tuna Vegetable Salad, and Imitation Crab Salad finished product labels list “fish” and/or “shellfish” in the Contains statement, rather than the common or usual name of the fish species used.
2. The ingredient lists for the Sub-Tuna Salad, Key West Rotini, and Tuna Vegetable Salad products declare the ingredient “algin derivative.” This is not an appropriate common or usual name for an algin ingredient.
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 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 re-inspection 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 Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
You should respond in writing within fifteen (15) working days of receiving this letter. Your response should outline the specific steps you are taking to correct these violations, including an explanation of how your firm plans to prevent these violations, or similar violations from occurring again. More specifically, your response should include documentation of the corrections and/or corrective actions your firm has taken. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed.
Please submit your response to Seri Essary, Compliance Officer, at the above letterhead address. If you have any questions please contact Ms. Essary at (313) 393-8150.
Sincerely,
/S/
Art O. Czabaniuk
District Director
Detroit District Office
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