Three seafood processors received warning letters from U.S. Food and Drug Administration district offices in the second week of April. The Montana Fish Company, Cloverdale Foods and Sunrise Meats, Inc. were all warned for violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations.
Another food processing facility, Han Yang Oriental Food Manufacturing, received a warning letter after FDA inspectors found Listeria monocytogenes in the food manufacturing facility and for violations of Current Good Manufacturing Practice (CGMP) regulations. In a warning letter dated April 9, Meridian, North Dakota-based Cloverdale Foods was cited for failure to have and implement a written HACCP plan to control food safety hazards of pathogen growth and toxin formation, allergens and food additives and to detect metals. The firm was also warned for misbranding products, with violations including:
- Failure to declare all major food allergens present in products
- Failure to declare any ingredients on some bulk service containers
- Failure to list a complete list of ingredients by common or usual name in descending order of predominance by weight as well as sub-ingredients on sauce and shrimp patty packaging
- Failure to provide a nutrition label on sauce products
Sunrise Meats of Port Angeles, Washington, also received a warning letter dated April 9. In it, FDA warns the company president of violations to Seafood HACCP and misbranding. Violations included:
- Failure to conduct a hazard analysis for each kind of fish and fishery product produced and to list food safety hazards that are reasonably likely to occur
- Failure to implement the monitoring, record keeping and verification system listed in the company’s HACCP plans
- Failure to verify that the HACCP plan was adequate to follow critical limits for critical control points in Hot-Smoked Fish and Cold-Smoked Salmon (Lox) HACCP plans
- Failure to have a HACCP plan for smoked oyster products
- Failure to declare a major food allergen – the species of fish – on labels
- Failure to bear the common or usual name of food on labels
- Failure to include the name and place of business of the manufacturer, packer or distributor on product labels
Montana Fish Company received a warning letter dated April 10, warning the company for:
- Failure to conduct a hazard analysis for each kind of fish and fishery product processed and to implement a HACCP plan to control any food safety hazards reasonably likely to occur
- Failure to have a HACCP plan adequate to ensure the control of the hazard of scrombrotoxin formation by ensuring internal temperature of the product remains at 40 degrees F or below throughout transit
- Failure to take appropriate corrective action when a deviation from a critical limit occurred
- Failure to implement monitoring procedures and frequency that is listed in the HACCP plan
In a letter dated April 11, Han Yang Oriental Food Manufacturing was warned that FDA inspectors found Listeria monocytogenes in the facility during inspections on November 6 and 18, 2013. FDA said the locations where positive swabs were “significant in that they were found in locations that have a likelihood of a direct route of contamination into food.” FDA cited Han Yang Oriental Food for:
- Failure to ensure work-in-process is handled in a manner that protects against contamination
- Failure to handle and maintain equipment, containers and utensils used to convey, hold or store food in a manner to protect against contamination
- Failure to take all reasonable precautions to ensure production procedures do not contribute contamination from any source
- Failure to ensure the plant is constructed in a manner that floors may be adequately cleaned, kept clean and kept in good repair in such a manner as to prevent condensation from contaminating food and food-contact surfaces
- Failure to keep toilet facilities in good repair at all times
- Failure to ensure all food manufacturing, including packaging and storage, is conducted under such conditions and controls as are necessary to minimize the potential for growth of microorganisms or of the contamination of food
Recipients of these warning letters have 15 working days from receipt of the letter to outline specific steps it has taken to come into compliance with the law.
