Steris Isomedix Services, Inc. – FDA Warning Letter, Jun 21, 2010

On September 27, 2010, the FDA issued a Warning Letter to Steris Corporation following an inspection from June 8-21, 2010, at their Grand Prairie, Texas facility, which performs contract sterilization of medical devices. The inspection found the devices 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 C.F.R. Part 820.

Key violations included: 1. **Failure to establish finished device acceptance procedures (21 C.F.R. § 820.80(d))**: The firm lacked procedures for relative humidity (Rh) monitor placement and acceptance/rejection of Rh data during sterilization. For 30 of 71 customer records, only one monitor's data was reported, despite multiple monitors being used. Data points were selectively chosen to meet customer specifications, and not all raw data was consistently evaluated. 2. **Failure to control nonconforming product (21 C.F.R. § 820.90(a))**: The firm's CAPA procedure was not followed for out-of-specification Rh levels; non-conformities were not investigated, and only in-specification readings were reported to customers. 3.