FDA WARNING_LETTER - Stryer Biotech - October 18, 2007

On April 25, 2008, the FDA issued a Warning Letter to Stryker Biotech following a September-October 2007 inspection of their Hopkinton, MA facility, which manufactures Calstrux, OP-1 Implant, and OP-1 Putty. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act and Quality System (QS) regulation.

A primary violation was the failure to obtain an Investigational Device Exemption (IDE) before initiating clinical investigations of the OP-1 Implant for new, unapproved indications (in combination with other substances). This rendered the devices adulterated under section 501(f)(1)(B) and misbranded under section 502(o) due to lack of premarket approval (PMA) or IDE, and failure to submit a 510(k) notification for the new intended use.

Additional QS regulation violations (21 CFR Part 820) included: 1. Failure to adequately establish and maintain procedures for analyzing quality data (e.g., complaints, CAPA), specifically lacking clear definitions for "trending" and "statistical methods," leading to inadequate complaint analysis. The firm's response was deemed inadequate as the new procedure's trending definition was too broad to detect significant increases in complaints. 2. Failure to adequately implement changes for corrective actions (e.g., Corporate CAPA #2006-0