Penguin Juice Company, Inc. – FDA Warning Letter, Apr 5, 2010

The FDA inspected Penguin Juice Company, Inc. from March 18 to April 5, 2010, and found serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering their concentrated juice products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, several products were found to be adulterated under Section 402 and misbranded under Section 403 of the Act and 21 CFR Part 101.

Key violations include: 1. **HACCP Plan Implementation:** Failure to implement a written HACCP plan, specifically regarding the pasteurization step for "100% Juice Concentrates" and "100% Juice Blend Concentrates" to control pathogens, and not meeting the critical limit for pasteurization. 2. **5-Log Pathogen Reduction:** Not performing a 5-log pathogen reduction measure in the same facility where final product packaging occurs. 3. **Sanitation Records:** Failure to maintain sanitation standard operating procedure records for various critical areas, including water safety, food contact surfaces, cross-contamination prevention, handwashing facilities, protection from contaminants, toxic compound control, employee health, and pest exclusion. 4. **Hazard Analysis:** Failure to identify undeclared allergens and food intolerance ingredients (milk, sulf