FDA WARNING_LETTER - Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasa - September 23, 2022

The FDA issued a Warning Letter to Akcaburgaz Mahallesi, Muhsin Yazicioglu Caddesi No:45/5 34522 Esenyurt/İstanbul Turkey, following an inspection from September 19-23, 2022. The firm manufactures ultrasound gel products, classified as devices, which were found to be adulterated due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820). Key violations include inadequate procedures for design validation (21 CFR 820.30(g)), complaint handling and Medical Device Reporting (MDR) (21 CFR 820.198(a)), and establishing requirements for suppliers (21 CFR 820.50(a)). Further deficiencies involved design change control (21 CFR 820.30(i)), personnel health and cleanliness practices (21 CFR 820.70(d)), ensuring adequately trained personnel familiar with USFDA regulations (21 CFR 820.25(a)), and maintaining device history records (DHRs) (21 CFR 820.184). The firm's responses were deemed inadequate, often lacking documentation of raw data, CAPA effectiveness, retrospective reviews, and personnel training. The FDA requires a written response within fifteen business days detailing specific corrective actions, prevention plans, and implementation timelines. Non-compliance may impact federal contracts and Class III device approvals.