FDA WARNING_LETTER - Steritec Products, Inc. - May 15, 2008

On April 29-May 15, 2008, an FDA inspection of Steritec Products, Inc., a manufacturer of medical devices including the Flash Integrator, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820). The devices were deemed adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to establish and maintain procedures for acceptance of incoming components (21 CFR 820.80(b)). Specifically, an incoming lot of (b)(4) for the Flash Integrator was accepted without testing, leading to a market withdrawal of three lots due to performance failures. 2. Failure of design output procedures to contain or reference acceptance criteria for incoming linseed oil (21 CFR 820.30(d)). 3. Failure to establish and maintain procedures for conducting design reviews, validating device design, and validating design changes (21 CFR 820.30(e), (g), & (i)). The firm failed to follow its own procedures and did not validate a design change (Change Order No (b)(4)). 4. Failure to establish and maintain procedures for quality audits and conduct such audits (21 CFR 820.22). No quality audit was conducted in 2005, and the 20