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A total of 258 persons infected with the outbreak strains ofSalmonella Bareilly (247 persons) or Salmonella Nchanga (11persons) have been reported from 24 states and the District ofColumbia. 32 ill persons have been hospitalized, and no deaths havebeen reported. Collaborative investigation efforts of state, local,and federal public health agencies indicate that a frozen rawyellowfin tuna product, known as Nakaochi Scrape, from Moon MarineUSA Corporation is the likely source of this outbreak. FDA 483 Inspection Report (download PDF): Mr. Dominic Sebastian, Managing Director, Moon Fishery (India) Pvt.Ltd., 11/722/D, Chemical Industrial Estate, Aroor, Alleppy 688534Kerala India Observation No. 1 Your HACCP plan does not list one or more critical control pointsthat are necessary for each of the identified food safety hazards. Specifically, your HACCP plan for raw tuna does not list criticalcontrol points at the following process step to control the hazardsof Clostridium botulinum, histamine and allergens. A. There is no Critical Control Point listed on your HACCP plan forthe process of cutting, scraping, and vacuum packaging performed inyour processing room, kept at a temperature of REDACTED C tocontrol the hazard of pathogen growth and histamine formation. B. There is no Critical Control Point listed on your HACCP plan forClostridium botulinum and allergen labeling applied to the primarypackaging. C. There is no Critic al Control Point listed on your HACCP planfor metal detection. D. In your HACCP plan for receiving tuna, the only critical limitlisted is temperature, with no critical limit listed for vesselmonitoring and histamine testing records to show that tuna was nottemperature abused on the harvesting vessel. Observation No. 2: You are not monitoring the sanitation conditions and practices withsufficient frequency to assure conformance with Current GoodManufacturing Practices including safety of water that comes intocontact with food or food contact surfaces, including water used tomanufacture ice condition and cleanliness of food contact surfacesmaintenance of hand washing, hand sanitizing and toilet facilities,and protection of food, food packaging material, and food contactsurfaces from adulteration. A. You are not monitoring the safety of water as evidenced by: 1. Tanks used for storage of process waters have apparent visibledebris, filth and microbiological contamination. Sand and activatedcarbon filter units used in manufacturing of water are notsanitized, and ventilation for tanks is not filtered to protectagainst contamination. There is no laboratory analysis for waterused in ice manufacturing at the REDACTED facility to show thewater used to make ice is potable. Ice manufacturing lacks sanitarycontrols: ice manufacturing equipment at the Moon Fishery facilityis located outside and is susceptible to adulteration from pestsand the environment. Apparent bird feces were observed on the icemanufacturing equipment at Moon Fishery; insects and filth wereobserved in and on the equipment. Ice manufacturing equipment atyour REDACTED facility is rusty and situated so that the ice cannotbe protected against adulteration, as the ice manufacturing processis constructed into the flooring of the ice facility. Tunaprocessed at your facility, which is consumed raw or cooked, comesin direct contact with water and ice. B. You are not monitoring the condition or cleanliness of foodcontact surfaces as evidenced by: 1. Some of the floor and wall tiles in the tuna processing area arebroken and cracked, not allowing for proper cleaning. 2. After cleaning, the ceiling directly above the in-process tunaline was observed to have visible product residue. 3. After cleaning, product residues and rust were observed onknives and utensil storage boxes. These knives are used to cut rawtuna. C. You are not monitoring protection from adulterants as evidenced: 1. Peeling paint was observed directly above the in-process tunaline. D. You are not monitoring hand washing, hand sanitizing and toiletfacilities as evidenced by: 1. There was no hand drying devices available in the employee restrooms on the first floor. I am an expert from chemical-storagecabinet.com, while we provides the quality product, such as Corrosive Storage Cabinet , Biological Safety Cabinet Manufacturer, Medical Storage Cabinet,and more.
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