FDA WARNING_LETTER - Integra LifeSciences Corporation - August 25, 2011

On July 22, 2011, an FDA inspection of Integra LifeSciences Corporation in Plainsboro, New Jersey, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) for medical devices, including Duragen XS Dural Regeneration Matrix and Integra Artificial Skin. The devices were deemed adulterated under section 501(h) of the Act.

Key violations include: 1. **Environmental Control (21 CFR 820.70(c)):** Failure to control environmental conditions, specifically persistent mold contamination in manufacturing areas since June 2009, despite a third-party report indicating product integrity risk. The firm continued manufacturing approximately (b)(4) lots. Inadequate and ambiguous re-sampling procedures for Out of Specification (OOS) results were also cited, along with unperformed HEPA filter velocity verifications. 2. **Process Validation (21 CFR 820.75(a)):** Inadequate cleaning validation for manufacturing tanks, lacking a (b)(4) coverage test, and continued use of unvalidated equipment. The WFI Distribution System's TOC and conductivity sensor validation lacked a Performance Qualification (PQ), and data from an unvalidated recorder was used to release quarantined products. 3. **Nonconforming Product Control (21 CFR 820.90(a)):** Failure to adequately investigate nonconforming products, including