FDA WARNING_LETTER - Gilman Cheese Corporation - April 21, 2011

The FDA conducted an inspection of Gilman Cheese Corporation's low-acid and acidified food manufacturing facility from April 13-21, 2011. The inspection revealed significant deviations from the Low-Acid Canned Foods (LACF) regulations (21 CFR 113), which are mandatory for manufacturers of such products.

Key violations include: 1. **Failure to file scheduled processes:** The firm manufactures several pasteurized processed cheese products (with onion, jalapeno, and plain cheese food) that are not covered under their currently filed scheduled process with the FDA, violating 21 CFR 108.35(c)(2). 2. **Inaccessible scheduled processes:** The processes and retort venting procedures, including the scheduled process, were not posted near equipment or readily available to operators and lab technicians, violating 21 CFR 113.87. The Quality Assurance Manager was also unaware of a filed process. 3. **Failure to record critical factors:** The firm is not monitoring and recording the amount of a critical factor, (b)(4), in shelf-stable pasteurized processed cheese products, as specified by their process authority, violating 21 CFR 113.100(a). 4. **Inadequate container coding:** Sealed containers are not marked with a code identifying the establishment, product, year, day, and period packed, as required by 21