FDA EIR - Avanti Frozen Foods Private Limited - May 09, 2023

An FDA surveillance inspection of Avanti Frozen Foods Private Limited, located in Gopalapuram, Andhra Pradesh, India, was conducted from May 5 to May 9, 2023. The inspection aimed to assess the company's compliance with regulations governing Fish and Fishery Products (21 CFR 123) and general food safety practices under the Federal Food, Drug and Cosmetic Act, focusing on their processing of raw, individually quick-frozen (IQF) L. vannamei shrimp for export to the U.S. No formal Form FDA 483 Inspectional Observations were issued; however, seven key discussion items were addressed with management. These included sanitation concerns such as brown residue in ice equipment and an unclean freezer floor. Issues with inadequate temperature monitoring in the QC lab fridge and incorrect glaze water temperature records were noted. Record-keeping deficiencies involved undated HACCP plans and maintenance records, and missing production dates. Environmental monitoring procedures needed correction, as trolleys were misidentified as food contact surfaces in the SOP, and staff did not follow proper swabbing instructions. Furthermore, cleaning agent documentation lacked ingredient lists and manufacturer’s mixing instructions. Lastly, metal detector cleaning records were absent despite calibration requirements. In response, Avanti Frozen Foods management committed to immediate voluntary corrective actions. These included enhanced cleaning protocols, installing calibrated temperature monitoring devices, updating and dating all records, revising environmental monitoring SOPs and retraining staff, clarifying cleaning agent usage with the manufacturer, and incorporating metal detector belt cleaning into their sanitation procedures. The firm promptly began addressing these observations.