FDA WARNING_LETTER - Steris Corporation - June 17, 2008

On September 25, 2008, the FDA issued a Warning Letter to Steris Corporation following an inspection of its Steris Isomedix Inc. facility in Coventry, RI, from June 4 to June 17, 2008. The inspection revealed that the firm's medical device sterilization processes were not in conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulations (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act.

Key violations included: 1. **Failure to control nonconforming product (21 CFR 820.90(a))**: Two ethylene oxide loads (1031 and 39189) with deviations in steam injection duration, aeration temperature, or ethylene oxide injection time were released and shipped to customers. The firm's CAPA was inadequate as it did not address previously processed nonconforming product. 2. **Failure to establish adequate CAPA procedures (21 CFR 820.100(a)(3))**: Load R070215-07 was processed using an unapproved cycle revision due to a server migration issue. The firm's response was inadequate as it did not provide evidence that proposed process controller replacements would prevent recurrence. 3. **Failure to establish adequate finished device acceptance procedures