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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

FDA 483 Inspection of Tuna Scrape Plant finds Violations

A total of 258 persons infected with the outbreak strains of Salmonella Bareilly (247 persons) or Salmonella Nchanga (11 persons) have been reported from 24 states and the District of Columbia. 32 ill persons have been hospitalized, and no deaths have been reported. Collaborative investigation efforts of state, local, and federal public health agencies indicate that a frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation is the likely source of this outbreak.

form 483.JPGFDA 483 Inspection Report (download PDF):

Mr. Dominic Sebastian, Managing Director, Moon Fishery (India) Pvt. Ltd., 11/722/D, Chemical Industrial Estate, Aroor, Alleppy 688534 Kerala India

Observation No. 1

Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.

Specifically, your HACCP plan for raw tuna does not list critical control points at the following process step to control the hazards of Clostridium botulinum, histamine and allergens.

A. There is no Critical Control Point listed on your HACCP plan for the process of cutting, scraping, and vacuum packaging performed in your processing room, kept at a temperature of REDACTED C to control the hazard of pathogen growth and histamine formation.

B. There is no Critical Control Point listed on your HACCP plan for Clostridium botulinum and allergen labeling applied to the primary packaging.

C. There is no Critic al Control Point listed on your HACCP plan for metal detection.

D. In your HACCP plan for receiving tuna, the only critical limit listed is temperature, with no critical limit listed for vessel monitoring and histamine testing records to show that tuna was not temperature abused on the harvesting vessel.

Observation No. 2:

You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice condition and cleanliness of food contact surfaces maintenance of hand washing, hand sanitizing and toilet facilities, and protection of food, food packaging material, and food contact surfaces from adulteration.

A. You are not monitoring the safety of water as evidenced by:

1. Tanks used for storage of process waters have apparent visible debris, filth and microbiological contamination. Sand and activated carbon filter units used in manufacturing of water are not sanitized, and ventilation for tanks is not filtered to protect against contamination. There is no laboratory analysis for water used in ice manufacturing at the REDACTED facility to show the water used to make ice is potable. Ice manufacturing lacks sanitary controls: ice manufacturing equipment at the Moon Fishery facility is located outside and is susceptible to adulteration from pests and the environment. Apparent bird feces were observed on the ice manufacturing equipment at Moon Fishery; insects and filth were observed in and on the equipment. Ice manufacturing equipment at your REDACTED facility is rusty and situated so that the ice cannot be protected against adulteration, as the ice manufacturing process is constructed into the flooring of the ice facility. Tuna processed at your facility, which is consumed raw or cooked, comes in direct contact with water and ice.

B. You are not monitoring the condition or cleanliness of food contact surfaces as evidenced by:

1. Some of the floor and wall tiles in the tuna processing area are broken and cracked, not allowing for proper cleaning.

2. After cleaning, the ceiling directly above the in-process tuna line was observed to have visible product residue.

3. After cleaning, product residues and rust were observed on knives and utensil storage boxes. These knives are used to cut raw tuna.

C. You are not monitoring protection from adulterants as evidenced:

1. Peeling paint was observed directly above the in-process tuna line.

D. You are not monitoring hand washing, hand sanitizing and toilet facilities as evidenced by:

1. There was no hand drying devices available in the employee rest rooms on the first floor.

  • Janet M.

    If we are going to allow imports of potentially hazardous foods like this into our country there should be some way to assure that the facility that is producing the product is sanitary. Although the system isn’t perfect in our country, at least we do have inspection of processing facilities.