FDA WARNING_LETTER - Sterling Foods LLC - February 28, 2013

The FDA conducted an inspection of Sterling Foods LLC's Union City, California facilities from February 20-28, 2013, revealing serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110. These deficiencies render the firm's food products adulterated per Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include: 1) Failure to implement effective measures against metal or extraneous material inclusion (21 CFR 110.80(b)(8)), evidenced by broken conveyor belts, missing aerator spikes, and improperly functioning metal detectors. 2) Failure to maintain equipment in an acceptable, sanitary condition (21 CFR 110.80(b)(1)), with food debris on direct food contact surfaces and high ATP swab readings indicating inadequate cleaning. 3) Failure to protect work-in-process from contamination (21 CFR 110.80(b)(5)), observed with unpackaged food stored near floor sweeping. 4) Failure to remove litter and waste attracting pests (21 CFR 110.20(a)(1)), with rotting food waste bins and debris piles near buildings. 5) Failure to provide adequate pest protection (21 CFR 110.20(b)(7)), due to open doors and gaps allowing pest access. The FDA requires Sterling Foods to provide a written response within fifteen working days detailing specific corrective actions, prevention plans, and a timetable for implementation. Failure to promptly correct these violations may lead to legal action, including seizure and injunction, and re-inspection fees. The firm must investigate the root causes of these systemic issues.