Advanced Sterilization Products – FDA Warning Letter, Sep 28, 2009

The FDA issued a Warning Letter to Johnson & Johnson's Advanced Sterilization Products (ASP) on March 12, 2010, following an inspection from June 1 to September 28, 2009, at their Irvine, California facility. The inspection revealed that ASP's STERRAD sterilizers, CIDEX disinfectants, and Evotech Cleaner and Reprocessor were 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 violations included: 1. **Failure to establish and maintain adequate procedures for verifying or validating corrective and preventive actions (CAPA)** (21 CFR § 820.100(a)(4)). Examples cited were inadequate effectiveness checks for oil misting issues in STERRAD sterilizers (CAPA 07-0000027) and no effectiveness check for hydrogen peroxide contact issues with STERRAD CycleSure Biological Indicators (BIs) (CAPA 08-000008). ASP's response was deemed inadequate for these points. 2. **Failure to establish and maintain adequate procedures for the verification of design changes** (21 CFR § 820.30(i)). Specifically, the online