FDA Warning Letter to Moon Fishery

On April 19, 2012 through April 24, 2012 the U.S. Food and Drug Administration (FDA) inspected Moon Fishery in India, the facility that produced the recalled Nakaochi Scrape raw tuna linked to the large Salmonella Bareilly and Salmonella Nchanga outbreak in the U.S. The same company issued a recall of raw Grade AA and AAA tuna strips, intended for sushi, last week.

As a result of that inspection, the FDA issued a warning letter to the company detailing the violations of the Hazard Analysis and Critical Control Points (HACCP) plan that every food facility is required to develop and follow. Parts of the letter were redacted.

In the letter, the agency states that the facility’s HACCP plan doesn’t include the critical control points (CCP) necessary for the hazards identified for the products they produce.

• Most significantly, there is “no Critical Control Point listed on your HACCP plan for the processing steps of cutting, scraping, and vacuum packaging performed in your processing room, kept at a temperature of [redacted], to control the hazard of pathogen growth and histamine formation.
• There is no CCP for Clostridium botulinum and allergen labeling or metal detection.
• The only critical limit in the plan for receiving tuna is for temperature control, with nothing for vessel monitoring to show the temperature of the fish stayed within safe levels during harvest and transport.
• The facility did not monitor the safety of the water used to process the tuna. Investigators found “visible debris, filth, and microbiological contamination” in the tanks that stored processing water.
• The ice used in processing was not tested to prove it was potable.
• The facility had broken and cracked floor and wall tiles which can harbor bacteria and be difficult to clean.
• Product residue and rust were found on knives and storage containers after cleaning.
• Peeling paint was observed above the tuna line.
• No hand drying devices were found in the employee rest rooms.

Several of these points were raised in Food Poisoning Bulletin’s April conversation with Dr. Ted Johnson, professor of biology at St. Olaf College. Dr. Johnson thought that contaminated water was a prime contender for the bacteria; and the facility was cited for potentially unpotable water and lack of temperature control.

As of May 2, 2012, 258 people have been sickened in the outbreak linked to the raw scraped yellowfin tuna. Thirty two people have been hospitalized, and there have been no deaths. The case count will most likely grow. We’ll keep you informed.