FDA WARNING_LETTER - Sirob Imports, Inc. - October 23, 2012

On October 10-23, 2012, the FDA inspected Sirob Imports, Inc. in Lindenhurst, NY, identifying serious violations in acidified foods (21 CFR Part 108, 114), juice processing (21 CFR Part 120), and Current Good Manufacturing Practices (CGMP) (21 CFR Part 110). These violations render products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: * **Acidified Foods:** Failure to file scheduled processes for products like garlic in water (repeat violation), inadequate thermal processing, improper container coding (repeat), lack of trained supervision (repeat), and failure to maintain records (repeat). * **Juice HACCP:** Absence of written hazard analyses and HACCP plans for lemon and lime juices, failure to include 5-log reduction control measures, and lack of written procedures for imported juice concentrates (21 CFR 120.14). * **CGMP:** Insufficient monitoring of water safety (e.g., non-food grade hose, no backflow prevention - repeat), inadequate handwashing and glove use by employees (repeat), unsecured jewelry (repeat), lack of hand sanitizing facilities (repeat), and evidence of rodent activity (repeat). * **General CGMP:** Failure to provide adequate employee training (repeat),