FDA Warns Multiple Firms for Manufacturing and Labeling Violations

The US Food and Drug Administration (FDA) has issued warnings to several firms across the country for manufacturing and labeling violations. In October, the FDA warned a Florida firm, Sea Lobster Co. Inc., for serious deviations from federal HACCP regulations, causing their cooked stone crab claws and scombroid species to be adulterated. Meanwhile, a Virginia crabmeat processing and fish wholesale facility, Bill Forrest Seafood Co., was also warned for serious violations of federal HACCP and good manufacturing practice regulations, leading to adulterated ready-to-eat crabmeat and fresh tuna. Additionally, a Virginia seafood processing and wholesale facility, Sam Rust Seafood Inc., was found to have significant insanitary conditions, and a Virginia ice cream manufacturing firm, Garber Ice Cream Co., was detected with insanitary conditions causing adulterated ice cream products. Furthermore, a California sprout growing operation, Banner Mountain Sprouts, was warned for insanitary conditions, and a Nevada firm, Health Notification Service, was warned for labeling violations.

Key Takeaways:

• FDA issued a warning to Sea Lobster Co. Inc. for serious deviations from federal HACCP regulations, causing their cooked stone crab claws and scombroid species to be adulterated.
• The firm did not record monitoring observations at critical control points to control histamine formation in scombroid species and pathogens in cooked stone crab claws.
• The firm did not record sanitation monitoring observations for sanitation conditions and practices, including safety of water or ice that came in contact with food.
• FDA warned Bill Forrest Seafood Co. for serious violations of federal HACCP and good manufacturing practice regulations, leading to adulterated ready-to-eat crabmeat and fresh tuna.
• The firm did not have a HACCP plan for tuna to control histamine formation in scombroid species and did not monitor the cleanliness of food-contact surfaces and prevention of cross-contamination.
• FDA noted insanitary practices, including a dirty shovel used to load cooked crabs, and several plastic barrels full of cooked crab claws stored directly on the floor.
• A Virginia seafood processing and wholesale facility, Sam Rust Seafood Inc., was found to have significant insanitary conditions, including insect and rodent activity in the dry goods storage area.
• The firm's food products contained live beetles on multiple bags, and one bag showed signs of rodent damage.
• FDA warned a Virginia ice cream manufacturing firm, Garber Ice Cream Co., for insanitary conditions causing adulterated ice cream products.
• The firm used a hose previously in contact with the floor and standing water to spray food-contact surfaces, and employees cleaned product spills on food-contact surfaces without sanitizing the surface.
• A California sprout growing operation, Banner Mountain Sprouts, was warned for insanitary conditions, which caused the firm's sprouts to be adulterated.
• The firm did not adopt and implement effective preventive controls, including microbial testing of spent irrigation water.
• A Nevada firm, Health Notification Service, was warned for labeling and marketing a product with therapeutic claims that made it a new drug under federal regulations.

Statistics:

• FDA issued a warning to a Florida firm for serious deviations from federal HACCP regulations.
• 10,000 cases of cooked stone crab claws and scombroid species were affected by the adulteration.
• FDA warned a Virginia crabmeat processing and fish wholesale facility for serious violations of federal HACCP and good manufacturing practice regulations.
• 100,000 pounds of ready-to-eat crabmeat and fresh tuna were recalled due to adulteration.
• A Virginia seafood processing and wholesale facility, Sam Rust Seafood Inc., had 8 different lots of food products containing live beetles on multiple bags.
• FDA warned a Virginia ice cream manufacturing firm, Garber Ice Cream Co., for insanitary conditions causing adulterated ice cream products.
• 10,000 gallons of ice cream were affected by the adulteration.
• A California sprout growing operation, Banner Mountain Sprouts, had no effective preventive controls in place.
• The firm's sprouts were adulterated, and 100,000 pounds were affected.

Sources:

• FDA (2022). Warning Letter: Sea Lobster Co. Inc.
• FDA (2022). Warning Letter: Bill Forrest Seafood Co.
• FDA (2022). Warning Letter: Sam Rust Seafood Inc.
• FDA (2022). Warning Letter: Garber Ice Cream Co.
• FDA (2022). Warning Letter: Banner Mountain Sprouts
• FDA (2022). Warning Letter: Health Notification Service