FDA WARNING_LETTER - Steris Isomedix Services - January 08, 2014

The FDA issued a Warning Letter to STERIS Corporation following an inspection of its Libertyville, Illinois facility from October 29, 2013, to January 8, 2014. The facility sterilizes medical devices, which were found to be adulterated under Section 501(h) of the Act due to non-conformity with current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation (21 CFR Part 820). Key violations included the failure to establish and maintain adequate procedures for corrective and preventive actions (21 CFR 820.100), specifically regarding escalation of global non-conformances and comprehensive investigation of data manipulation/falsification incidents. The firm also failed to adequately analyze quality data (21 CFR 820.100(a)(1)), disseminate quality problem information to responsible personnel (21 CFR 820.100(a)(6)), and properly investigate nonconformities (21 CFR 820.100(a)(2), 820.100(b)). Furthermore, management failed to review the quality system's effectiveness (21 CFR 820.20(c)), and the organizational structure was inadequate, leading to conflicts of interest in dosimetry analysis (21 CFR 820.20(b)). Deficiencies in process control procedures for dosimeter analysis (21 CFR 820.70(a)), inadequate software validation (21 CFR 820.70(i)), and a lack of established complaint handling procedures (21 CFR 820.198(a)) were also cited. The FDA deemed the firm's responses inadequate, requiring prompt corrective actions, documentation, and a timetable within 15 working days to prevent further regulatory actions like seizure or injunction. A comprehensive, global assessment of operations is expected.