FDA WARNING_LETTER - Golden Pacific Foods Inc. - April 02, 2010

On July 29, 2010, the FDA issued a Warning Letter to Golden Pacific Foods, Inc. following an inspection on April 1-2, 2010, which revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The firm's shrimp chips were deemed adulterated due to insanitary conditions and misbranded under Section 403 of the Act. Key violations included: 1. **Lack of HACCP Plan:** No written HACCP plan for shrimp chips to control hazards like pathogen survival, undeclared sulfites, milk, eggs, or soy. 2. **Inadequate Sanitation Monitoring:** Failure to sufficiently monitor sanitation conditions, evidenced by numerous deficiencies such as food residues on contact surfaces, lack of backflow prevention, soiled equipment, unlabeled chemicals, employee hygiene issues (e.g., wiping nose, eating in production area), and pest infestations (rodent excreta, spiders). 3. **No Sanitation Records:** Absence of sanitation monitoring records for the eight key sanitation conditions and practices. 4. **Insufficient Import Affirmative Steps:** Inadequate affirmative steps for imported shrimp crackers, including foreign HACCP plans that failed to identify undeclared allergens/intolerance substances and lack of written guarantees from foreign processors certifying compliance with