FDA WARNING_LETTER - Beach Products, Inc. - April 06, 2011

The FDA issued a Warning Letter (11-ATL-17) to Beach Products, Inc. following a March 7 - April 6, 2011 inspection of its pharmaceutical manufacturing facility, Pharmaceutical Associates, Inc. in Greenville, SC. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering the firm's drug products adulterated under 21 U.S.C. § 351(a)(2)(B). The firm's April 22, 2011 response was deemed insufficient. Key violations include the Quality Control Unit's failure to follow written procedures, leading to product release without proper review or investigation closure. The firm lacked adequate written procedures for production and process controls, specifically failing to validate manufacturing processes and prevent plastic particle contamination. Products failing specifications were not rejected, and unexplained discrepancies or batch failures were not thoroughly investigated. The firm also failed to establish time limits for production phases, adequately manage returned drug products, and conduct comprehensive annual product reviews. The FDA requires prompt corrective actions, including immediate QA personnel retraining, process validation, hold time studies, and a plan for affected products on the market. Failure to correct these violations may result in legal action, including seizure and injunction, and could impact export certificates, drug application approvals, and federal contracts. A written response detailing corrective steps and timelines is required within fifteen working days.