FDA 483 - Haifa Smoked Fish - July 03, 2002

During an inspection conducted by the Food and Drug Administration (FDA) on June 24, 25, and July 3, 2002, Haifa Smoked Fish, Inc., a smoked fish processor, received an FDA Form 483 documenting significant observations. The inspection revealed several deviations from regulatory standards, primarily concerning food safety and sanitation practices. A critical observation was the firm's Hazard Analysis and Critical Control Point (HACCP) plan, which was found to be insufficiently specific, failing to list various fish species covered by the plan. Furthermore, operational deficiencies were noted in thawing procedures, with frozen Escolar observed thawing at ambient temperature, contrary to the firm's process schedule requiring a controlled cooler environment. Sanitation and personnel hygiene were also areas of concern, as workers were seen hanging rubber work gloves on racks of fish and reusing them without proper rinsing. Additionally, uncovered and unpackaged whitefish were stored in a freezer with excessive condensation dripping from the ceiling, posing a contamination risk. These observations highlight the need for Haifa Smoked Fish, Inc. to implement comprehensive corrective actions to ensure compliance with food safety regulations, enhance their HACCP plan, improve thawing protocols, and reinforce stringent hygiene and storage practices to protect public health.