FDA WARNING_LETTER - CeraSys, Incorporated - May 04, 2010

An FDA inspection of CeraSys, Incorporated, conducted from April 28 to May 4, 2010, revealed significant violations concerning the manufacturing of CeraSys ZR zirconia dental blocks, classified as a medical device. The device was found to be adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Key QS deficiencies included failures to establish and maintain procedures for design control (820.30(a)), corrective and preventive actions (820.100(a)), complaint handling (820.198(a)), process validation (820.75(a)), equipment calibration and maintenance (820.72(a)), purchasing controls and supplier evaluation (820.50(a)), device master records (820.181), and personnel training (820.25(b)). Furthermore, the device was misbranded under 21 U.S.C. 352(t)(2) for failing to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803), specifically lacking written MDR procedures (803.17). The device was also misbranded under 21 U.S.C. 352(o) due to an incomplete device listing, specifically for the porcelain powder used in manufacturing. The firm's response was received late and not reviewed. CeraSys must promptly correct these violations within fifteen working days, providing documentation and a timetable for future actions. Failure to comply could lead to regulatory actions such as seizure, injunctions, civil money penalties, and impact federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter emphasizes the firm's responsibility to investigate and correct all underlying issues.