Artegraft, Inc. – FDA Warning Letter, Mar 8, 2010

On February 22, 2010, an FDA inspection of Artegraft, Inc. in North Brunswick, NJ, identified significant violations of Current Good Manufacturing Practice (CGMP) requirements for medical devices, specifically Artegraft (vascular graft) and D-Clot (thrombectomy catheter system). The inspection concluded on March 8, 2010, with a Form FDA-483 issued.

The FDA determined Artegraft's devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with 21 CFR Part 820 (Quality System Regulation). Key violations include:

1. **Failure to identify and prevent recurrence of nonconforming product (21 CFR § 820.100(a)(3))**: Numerous complaints regarding leaking Artegraft products were not effectively addressed. Corrective actions, such as adding a process check or an additional manufacturing step, were ineffective, as evidenced by continued complaints. A Corrective Action Request (CAR) was not opened at the time of inspection, and a proposed CAR-2010-3 lacked sufficient detail and validation plans.

2. **Failure to verify/validate changes to specifications, methods, processes, or procedures (21 CFR § 820.70(b))**: Artegraft failed to validate the impact of extending sterilization