FDA WARNING_LETTER - arrowhead de llc, - February 21, 2012

This FDA Warning Letter (2012-NOL-21) was issued to Arrowhead DE LLC, DBA Arrowhead Medical Device Technologies, following an inspection from February 13-16 and 21, 2012. The inspection revealed that the firm, which manufactures orthopedic products and surgical instruments, had adulterated devices under Section 501(h) of the Federal Food, Drug, and Cosmetic Act. Their manufacturing, packing, storage, or installation methods did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to adequately validate sterilization processes (21 CFR 820.75(a))**: The firm's sole validation documentation for gamma sterilization was insufficient, stating that each batch required separate validation. Packaging integrity data was also missing. The firm's response, including a new protocol, was deemed inadequate as corrective actions were ongoing. 2. **Failure to establish and maintain procedures for nonconforming product disposition (21 CFR 820.90(b)(1))**: Three lots of devices were released despite a contract sterilizer failing to include a dosimeter. The firm's justification was retrospective, and their corrective action (revising SOP) was in progress and deemed inadequate. 3. **Failure to establish and maintain