FDA WARNING_LETTER - Parayil Food Products Pvt. Ltd. - June 07, 2013

On June 6-7, 2013, the FDA inspected Parayil Food Products Pvt. Ltd. in Kerala, India, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123), and mandatory requirements for acidified foods (21 CFR 108 and 21 CFR 114). The inspection resulted in an FDA-483, and the firm's responses on July 1 and September 4, 2013, were deemed inadequate, particularly due to the lack of an updated HACCP plan.

Violations include: * **Seafood HACCP:** The HACCP plan for frozen scombrotoxin (histamine) forming fish and shelf-stable dried/pickled fish products was inadequate. It failed to list food safety hazards like *Clostridium botulinum* growth and toxin formation for vacuum-packaged products, and *Staphylococcus aureus* growth and toxin formation during drying. The plan also lacked critical control points for processing and refrigerated storage to control scombrotoxin (histamine) formation, and inadequate critical limits for raw material receiving (e.g., harvest vessel records, decomposition/sensory evaluation). Corrective action plans for scombrotoxin control were insufficient as they did not address the root cause of deviations. These issues render the products adulterated under 21 U.S.C. § 3