The first warning letters of the year issued by the U.S. Food and Drug Administration were delivered to a seafood processing facility in Hawaii and a dairy operator in Pennsylvania. A warning letter is FDA’s principal means of notifying members of a regulated industry of violations. The agency issues these letters to achieve prompt voluntary correction to violations. In a letter dated Jan. 3, 2014, FDA Public Health Service District Director Kathleen Lewis states that FDA inspectors found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and Current Good Manufacturing Practice regulation for foods during an inspection of the Nobuo T. Hawaii, Inc., processing facility during an inspection conducted September 23-28, 2013. The letter addresses both the findings of the facility inspection and a response to those findings, including submittal of a new HACCP plan from the seafood processor dated Oct. 14, 2013. FDA lists five significant food safety violations that remain to be addressed by Nobuo T. Hawaii, including:
- A HACCP plan that does not include critical limits to control the hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse or that address specific time or temperature controls.
- A HACCP plan that lists monitoring procedures that is not adequate to control the hazard of allergens at the Packing/Wrapping/Labeling critical control point.
- A corrective action plan within the HACCP plan that is inappropriate for controlling histamine. FDA states, “Scrombroid toxin fish that has not been frozen or processed sufficiently to destroy scrombroid toxin forming bacteria should not be exposed to temperatures about 40 F for more than 4 hours cumulatively, if any portion of that time is at temperatures above 70 F; or, for more than 8 hours cumulatively, as long as no portion of that time is at temperatures above 70 F.”
- A failure to take corrective action when a deviation from a critical limit to control histamine occurred. FDA does acknowledge that the seafood processing facility took appropriate corrective actions to temperature deviations between the dates of October 5 and 11, 2013, and that the agency will evaluate the adequacy and sustainability of those corrective actions during its next inspection.
- A failure to monitor the condition and cleanliness of food contact surfaces, prevent cross-contamination or exclude pests from the food plant, including the following: employees handling raw sushi-grade ahi tuna with hooks that were stored along a wall caked with debris; the preparation and weighing of the sushi-grade ahi tuna on a gouged cutting board, stained with debris; employees placing sushi-grade ahi tuna on trays that had not been cleaned or sanitized before use; fresh gilled and gutted ahi stored in direct contact with stained and dirty walls; and several flies and birds in the receiving area of the facility. FDA noted that Nobuo T. Hawaii provided documentation demonstrating corrections in response to FDA inspectors’ observations and that inspectors would look for those corrections during the next inspection.
The warning letter states that FDA plans to evaluate the adequacy and sustainability of any corrective actions taken at the processing facility during its next inspection. If violations are not promptly corrected, FDA can take further action to seize product or enjoin the firm from operating. Nobuo T. Hawaii had 15 days to respond to the warning letter. The second warning letter was issued by Dirk D. Sooter, FDA’s Public Health Service Philadelphia District Director, to a Pennsylvania dairy operation. According to a letter dated Jan. 8, 2014, tissue samples from a dairy cow sold for slaughter as food by Jacob F. Stoltzfus of Lititz, PA, in June 2013 tested positive for higher-than-acceptable levels of penicillin and flunixin. “The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated …” reads the letter from FDA to Stolzfus. The letter continues:
“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.
“For example, you fail to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).”
The FDA Warning Letter urges the dairyman to promptly correct violations of the Federal Food, Drug, and Cosmetic Act and to ensure the violations do not recur. If the dairy fails to correct the violations, FDA states that regulatory action such as seizure and/or injunction are possible results of inaction. Stoltzfus has 15 working days to respond to the Warning Letter.