FDA WARNING_LETTER - Eagle Products - June 25, 2010

From April 13 to June 25, 2010, the FDA inspected Eagle Products in Chicago, Illinois, a food manufacturing firm. The inspection revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) requirements (21 CFR Part 110), causing their food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Environmental swabs (sample 611088) tested positive for *Listeria monocytogenes* in the facility's processing room, indicating insanitary conditions. Specific violations included: 1. Failure to minimize microorganism growth and contamination (21 CFR 110.80(b)(2)), evidenced by *Listeria monocytogenes* on the floor and the use of high-pressure sprays likely to spread contamination. 2. Failure to maintain a sanitary production area (21 CFR 110.35(a)), observed when an employee placed a used toilet seat lid on a handwashing sink near the production area. 3. Improper cleaning and sanitizing (21 CFR 110.35(a)), with organic debris persisting on equipment, conveyor belts, and packaging materials after daily cleaning. 4. Poor facility maintenance (21 CFR 110.35(a)), including missing/damaged ceiling tiles with mold, and water