FDA 483 - SM Fish Corp. - September 09, 2016

An FDA inspection of SM Fish Corp., a seafood processor and food manufacturer in Far Rockaway, NY, was conducted from August 15 to September 9, 2016, resulting in a Form FDA 483 with eleven observations. The primary violations involved critical failures in the company's Hazard Analysis and Critical Control Point (HACCP) system. Inspectors found that SM Fish Corp. did not fully implement or verify recordkeeping procedures within its existing HACCP plan. Additionally, the company lacked a complete and signed HACCP plan for certain seafood products, failing to control potential hazards like physical contamination (e.g., metal inclusion) and chemical allergens. Key process monitoring equipment, specifically refrigerator thermometers, were uncalibrated, compromising temperature control accuracy.Significant sanitation issues were also identified. These included inadequate monitoring of food contact surface cleanliness, conditions suggesting a risk of cross-contamination, and ineffective measures to exclude pests. Critical control point monitoring records were not consistently reviewed or signed as required. Other lapses encompassed a lack of hand soap, insufficient sanitization of cleaned utensils and equipment, and debris accumulation on food processing machinery. Facility maintenance was also deficient, with observations of cracked floors, missing tiles, and a leaking air conditioning unit over food preparation areas. SM Fish Corp. is required to address these issues by implementing and verifying comprehensive HACCP controls, ensuring equipment calibration, enhancing sanitation practices, and rectifying all facility and equipment deficiencies to comply with food safety regulations.