Warnings, Recalls: Consumer Health Regulatory News

FDA placed Zhejiang, China, topical OTC drug firm Bicooya Cosmetics Ltd. on import alert until it corrects numerous “significant” good manufacturing practices violations, according to an Aug. 11 warning letter. Bicooyamarkets acne treatments, hand sanitizers, diaper rash lotion and shampoos regulated as OTC drugs. During a May 22-25 inspection, agency officials observed rodent feces throughout the building, including in proximity to a filling machine where OTC drug products are manufactured, and around raw materials and finished drug products, the Center for Drug Evaluation and Research’s Office of Manufacturing Quality stated. Bicooya also failed to clean, maintain and sanitize utensils at appropriate intervals to prevent malfunctions and contamination; did not have appropriate lab determination of satisfactory conformance to final specifications for batches of products – including the identity and strength of each active ingredient – prior to release; and failed to prepare batch production and control records with complete information relating to production and control of each batch of drug produced. FDA inspectors also observed facility staff altering information in analytical test reports during inspection.