# FDA WARNING_LETTER - Advanced Sterilization Products - September 28, 2009

Source: https://www.keypedia.com/records/warning_letter/advanced-sterilization-products/efeda958-2b1e-4a76-b768-0d9e9f95f44f

> FDA WARNING_LETTER for Advanced Sterilization Products on September 28, 2009. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Advanced Sterilization Products
- Inspection Date: 2009-09-28
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: 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

## Related Officers

- [Casey M. Tansey](https://www.keypedia.com/people/casey-m-tansey/0b1d10db-7e44-4d18-891e-06cdc0a32eab)
- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)
- [Charles E. Austin](https://www.keypedia.com/people/charles-e-austin/79354a7c-9f45-45df-a550-c6a7cfaa2343)
- [Karen Licitra](https://www.keypedia.com/people/karen-licitra/af762447-fb36-45a9-863c-7ac2dabef618)

Company: https://www.keypedia.com/companies/advanced-sterilization-products/f1fe9b2a-2cb0-4a87-b724-d5b33d19fbd3

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b