FDA WARNING_LETTER - Graham Shrimp Co., Inc. - May 06, 2014

On May 6, 2014, an FDA inspection of Graham Shrimp Company, Inc. in Bayou La Batre, Alabama, revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Parts 110 and 123). These violations render the firm's shrimp products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations cited on Form FDA 483 include: 1. Failure to have a written HACCP plan with essential elements for controlling reasonably likely food safety hazards [21 CFR 123.6(b)]. 2. Failure to conduct a hazard analysis for each seafood product processed or wholesaled [21 CFR 123.6(a)]. 3. Failure for the HACCP plan to be signed and dated upon initial acceptance, modification, and annually [21 CFR 123.6(d)].

The firm's May 6, 2014, response to the FDA 483 was deemed inadequate, lacking real-time data for proposed corrective actions and indicating some actions were incomplete. The FDA stated further action, including product seizure or injunction, may occur if violations are not promptly corrected. The firm must respond in writing within 15 working days,