Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistPushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi, an OTC drug product manufacturer based in Istanbul, Turkey, failed to conduct appropriate laboratory testing to verify that finished drug products met final specifications prior to release and distribution, in violation of Current Good Manufacturing Practice (CGMP) regulations. The company's manufacturing methods, facilities, and controls for drugs such as OTC wipes did not conform to CGMP requirements under 21 CFR parts 210 and 211, rendering their drug products adulterated. The violations were identified during FDA's review of records submitted in response to a section 704(a)(4) inspection request issued in September 2024.