FDA WARNING_LETTER - Pacific Northwest Tofu, LLC - August 29, 2012

The FDA conducted an inspection of the firm located at 6113 NE 92nd Drive, Portland, Oregon, from August 20-29, 2012, documenting serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR Part 110. These violations render the firm's food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to insanitary conditions. Key deficiencies include: improper handling of work in-progress leading to contamination; inadequate employee handwashing and hygiene practices, including failure to remove hand jewelry; insufficient cleaning and sanitizing operations for utensils and equipment; improper handling of raw materials; and the use of utensils not designed for proper cleaning. Furthermore, the facility exhibited significant structural and maintenance issues, such as floors not allowing adequate cleaning, buildings and fixtures not maintained to prevent adulteration (e.g., chipping paint, mold, hanging insulation), and ineffective pest control measures, including inadequate screening and failure to remove litter and waste. The firm also lacked sufficient space for material storage to maintain sanitary operations. The FDA requires a written response within 15 working days detailing corrective actions, plans to protect food from contamination, and pest control measures. Failure to implement lasting corrections may result in regulatory actions like product seizure, injunction, and assessment of re-inspection fees.