FDA WARNING_LETTER - Britto Seafoods Exports Pvt. Ltd. - September 28, 2013

An FDA inspection of Britto Seafoods Exports Pvt. Ltd. in Tuticorin, India, from September 23-28, 2013, revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's October 14, 2013, response to the FDA 483 was deemed inadequate, and a requested revised HACCP plan was not received. Consequently, the firm's products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key deficiencies identified include: 1) Failure to conduct a proper hazard analysis and list all reasonably likely food safety hazards, such as Staphylococcus aureus growth and toxin formation, in HACCP plans (21 CFR 123.6(a) and (c)(1)). 2) Failure to list necessary critical control points to control scombrotoxin (histamine) formation (21 CFR 123.6(a) and (c)(2)). 3) Inadequate critical limits in HACCP plans for controlling scombrotoxin (histamine) at various critical control points (21 CFR 123.6(c)(3)). 4) Inadequate monitoring procedures and frequencies listed in HACCP plans for critical control points (21 CFR 123.6(c)(4)). 5) Inappropriate corrective action plans that do not ensure the causes of critical limit deviations are corrected (21 CFR 123.7(b)).

The firm must respond in writing within 15 working days, outlining specific corrective actions, including a revised HACCP plan and five consecutive days of monitoring records. Failure to comply may lead to refusal of admission of imported products, including detention without physical examination (DWPE), and assessment of re-inspection fees.