FDA WARNING_LETTER - Negocios Industriales Real "N.I.R.S.A.", S.A. - August 10, 2011

On January 23, 2012, the FDA issued a Warning Letter to Negocios Industriales Real "N.I.R.S.A.", S.A. following an inspection of their seafood processing facility in Guayaquil, Ecuador, from August 8-10, 2011. The inspection revealed serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their canned tuna adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The firm's responses to the FDA-483 on August 24 and December 28, 2011, including a revised HACCP plan for canned tuna, were deemed inadequate.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for canned tuna failed to list reasonably likely food safety hazards: * *Clostridium botulinum* growth and toxin formation during thawing of frozen tuna loins, chunks, and flakes. * Metal inclusion from the use of a circular saw for fish processing. * Undeclared allergen (soy) from the use of soy flakes in vegetable broth. 2. **Missing Critical Control Points (21