The FDA's First Warning Letter Of 2014

By Sam Lewis

The U.S. Food and Drug Administration has delivered the year’s first notice of food safety violations to a Hawaiian seafood processing facility

The FDA issues warning letters as its fundamental means of notification for companies found in violation of industry regulations. The letters are intended to attain immediate and voluntary corrections to violations.

The FDA’s first warning letter of 2014 was issued to the Nobuo T. Hawaii, Inc., a seafood processing facility. The letter, dated Jan 3, 2014, was written by FDA’s Public Health Service District Director Kathleen Lewis. She 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 in an inspection of the facility in late September of last year. The letter lists the following violations:

• Not having a HACCP plan that includes limits to controlling bacterial pathogen growth and the formation of toxins from time and temperature abuse.
• Not having a HACCP plan listing the monitoring of adequate procedures in controlling allergens at packing, wrapping, or labeling critical control points.
• Having a corrective action plan within the HACCP plan that is not suitable for controlling histamine.
• Failing to take corrective actions when a change in a critical limit to control histamine occurred.
• Failing to monitor conditions and cleanliness of food contact surfaces, preventing cross-contamination, and eliminating pests from the facility. The letter reads, “Employees were observed handling raw sushi-grade ahi tuna fish using hooks which were stored along a wall ledge caked with debris.” Further, the letter states investigators found birds and insects throughout the facility’s receiving area.

In the warning letter, the FDA says it plans to evaluate how sufficient the corrective actions of Nobuo T. Hawaii, Inc. have been in the facility’s next inspection. Should violations not be corrected immediately, the FDA has the right to seize the company’s products or shut down operations until adequate corrections have been made.

As with all FDA warning letters, Nobuo T. Hawaii was given 15 days to respond. The company’s response “Should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections.”

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