FDA WARNING_LETTER - Penumbra, Inc. - August 28, 2009

On December 31, 2009, the FDA issued a Warning Letter to Penumbra, Inc. following an inspection from July 29 to August 28, 2009. The inspection revealed that Penumbra's Neuron Intracranial Access System devices (Models 053, 070, and Advanced 070) 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 C.F.R. Part 820).

Key violations included: 1. **Failure to establish and maintain adequate CAPA procedures (21 C.F.R. § 820.100(a))**: Issues included an inadequate recall notification for a Class I recall and insufficient retraining for nonconforming material. 2. **Failure to verify or validate CAPA effectiveness (21 C.F.R. § 820.100(a)(3))**: Multiple NCRs showed corrections without verification/validation or systemic action. 3. **Failure to establish and maintain adequate complaint handling procedures (21 C.F.R. § 820.198(a) and (d))**: Physician Evaluations were not reviewed as potential complaints/MDR