FDA Letter Says Products are “Adulterated” Due to Manufacturing Violations
New Jersey-based Products Africana has received a warning letter from the U.S. Food and Drug Administration (FDA) stating that the company has violated Current Good Manufacturing (CGMP) Regulations in Manufacturing, Packaging or Holding Human Food. The company’s fermented cornmeal products (Ga and Fanti Kenkey) and Hot pepper sauce with dried shrimp products are subsequently adulterated, the letter states. The FDA cited problems with maintaining the building and other physical facilities at the plant.
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The May 9th letter states that the products “have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.” The FDA said Products Africana failed “to maintain buildings, fixtures and other physical facilities of the plant.”
The company’s fish and fishery products are also adulterated, the letter said. The FDA said it discovered “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation”. The agency notes that the company is required to have a hazard analysis for each kind of fish and fishery product. However, the letter states, Products Africana “does not have a HACCP plan for Hot pepper sauce with dried shrimp (Shetor) to control the food safety hazards of Clostridium botulinum toxin formation; pathogenic bacteria growth and toxin formation; and undeclared major food allergens.”
Among other things, regulators said the company does not have equipment to measure the pH of fermented cornmeal products. The pH of these products, Ga and Fanti Kenkey, should be at or below 4.6.
The FDA also expressed “serious concerns” about the growth of harmful bacteria, including Clostridium botulinum and Bacillus cereus.
Warning Letter Cites Pests, Mold, Chipping Paint
The FDA cited various violations at the Products Africana facility that make its products adulterated. For example, federal regulations require manufacturers to actively prevent pests from contaminating the products. According to the letter, however, FDA investigators found cockroach-like insects (both in the adult and larvae stage), fruit-fly-like insects, rodent excrement “too numerous to count”, a live mouse, a dead mouse, dead roaches and bird excrement.
The company has also failed to maintain buildings, fixtures and facilities as required by federal regulations, the letter states. FDA inspectors found mold-like substance in many different places around the facility. Notably, there was “approximately ten square feet of a mold like substance on the sheetrock wall surfaces underneath utility racks,”
The warning letter also cited holes in the walls and chipping paint around the facility, in areas where food is packaged or produced.
Additionally, the employee restroom is located near a food production area. The door is not self-closing, making conditions unsanitary.
The FDA also noted a lack of cleaning procedures, noting “Your firm does not have a cleaning procedure or document any cleaning of equipment or utensils in your facility. Your employees were seen using a detergent but no sanitizer to clean equipment and utensils.”
Furthermore, the company is required to use insecticides safely, in a manner that does not contaminate food products. According to the warning letter, however, investigators found insecticide containers stored in the same area where food is handled.
The letter cites many other violations and issues at the facility involving potential contamination. To name a few examples, investigators found that multiple cooking pots contained rust and corrosion on the interior surface, black debris on the interior of the mixer, and a rusty blade with its handle completely wrapped in tape.
The FDA also found pooling water at the facility, which can provide a breeding ground for pests.
Additionally, the company failed to remove garbage properly. FDA inspectors “observed pallets, debris, empty totes, metal racks, and leaves propped up against a storage container that was located within approximately 20 feet of the bay door of the facility and within approximately 10 feet of the storage container storing cornmeal.”
“The egregious conditions observed at Products Africana, Inc. imply that the management and the workers lack a basic knowledge and understanding of food sanitation and hygiene practices and how to implement them,” the FDA states.
Legal Help for Food Poisoning Victims
If you or someone you know became ill or injured through contaminated food products, you may have valuable legal rights. The food safety attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).