FDA 483 - Integra LifeSciences Corporation - August 25, 2011

This FDA Form 483 details significant violations at a medical device manufacturing facility.

**Facility and Operations:** The facility, located at 105 Morgan Lane, manufactures various Integra products and contract-manufactured items, including Integra skin and medical products, Integra Bilayer Matrix Wound Dressing, Integra Meshed Bilayer Matrix Wound Dressing, Integra Matrix Wound Dressing, TenoGuide, and Integra Dermal Regeneration Template. The operation involves clean rooms (ISO Class 7), Deionized Ultra-filtered Water systems, Water for Injection (WFI) systems, Integra Mixing Tanks, and Lyophilizers.

**Violations and Observations:** 1. **Unsuitable Building Design:** Visible mold was identified in equipment storage, DI water system closet, and WFI system mechanical room from June 2009 to the present. Third-party reports confirmed various mold types (Aspergillus/Penicillium-like, Stachybotrys, etc.), indicating employee exposure and potential product integrity compromise. Despite 17 Quality Plans (QPs) for remediation, manufacturing and distribution continued. 2. **Inadequate Process Validation:** * Cleaning validations for multiple equipment, including Integra Mixing Tanks, were deficient (e.g., inadequate area coverage tests). Equipment was used before re-evaluation or new validation. * The WFI Distribution System In-line Analyzer lacked a Performance Qualification, and its recorder's validation was unexecuted, yet data from it