FDA WARNING_LETTER - Ecometics, Inc. - September 07, 2018

The FDA inspected Ecometics, Inc., a drug manufacturing facility in Norwalk, CT, from August 17 to September 7, 2018, revealing significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211). The firm's drug products are considered adulterated and misbranded. Key CGMP deficiencies include inadequate cleaning procedures for equipment shared between drug and non-drug products (21 CFR 211.67(b)), failure to conduct appropriate microbiological testing for drug products (21 CFR 211.165(b)), an unvalidated water system (21 CFR 211.63), and an inadequate stability testing program with non-stability-indicating methods and missed intervals (21 CFR 211.166(a)). The stability issue was a repeat observation from a 2016 inspection, indicating inadequate executive management oversight. Additionally, Ecometics failed to fulfill its drug registration and listing obligations under section 510 of the FD&C Act, leading to misbranded drugs (sections 502(o), 502(a), 502(f)(2)). The firm was also distributing unapproved prescription drugs. Ecometics' responses were deemed inadequate. The FDA requires immediate corrective actions, including discontinuing shared equipment for drugs, providing detailed testing specifications, validating the water system, and implementing a comprehensive stability program CAPA. A CGMP consultant is strongly recommended. Failure to promptly correct these systemic issues may result in legal action, including seizure and injunction, and impact future approvals or export certificates. A written response within 15 working days is required.