Li Da Seafood Trading Inc. – FDA Warning Letter, Nov 4, 2011

On November 2 & 4, 2011, the FDA inspected Li Da Seafood Trading, Inc. and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render refrigerated, ready-to-eat tuna and vacuum-packaged hamachi adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for vacuum-packaged hamachi to control pathogen growth and toxin formation, including *Clostridium botulinum*. (21 CFR §§ 123.6(a) and (b)) 2. **Failure to Implement Recordkeeping:** No monitoring records for receiving and product storage Critical Control Points for "Fresh Tuna" to control histamine formation. The cooler lacked a continuous temperature data logger despite the HACCP plan indicating continuous recording. (21 CFR §§ 123.6(b) and (c)(4)) 3. **Lack of Sanitation Control Records:** No records for water safety, food contact surface cleanliness, cross-contamination prevention, handwashing/toilet facility maintenance, food protection from adulteration, toxic chemical control, employee health, and pest exclusion. (21 CFR § 123.11