Retro-Tech, LLC – FDA Warning Letter, Feb 1, 2008

This FDA Warning Letter, dated April 16, 2008, was issued to Retro-Tech, LLC following an inspection from January 11 to February 1, 2008. The inspection revealed that the firm's Retro-Tech® RTD Bacteriostatic Wound Dressing, a medical device, is adulterated under section 501(h) of the Act because its manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. **Quality System Deficiencies (21 C.F.R. § 820.20):** Failure of management to implement and maintain an adequate and effective quality system, specifically lacking approved procedures for contract manufacturing facilities. 2. **Design Validation (21 C.F.R. § 820.30(g)):** No procedures for design risk analysis, no evaluation of irradiation effects on anti-microbial drugs, and no stability testing for expiration dating. 3. **Design Plans (21 C.F.R. § 820.30(b)):** Absence of established and approved written design plans. 4. **Design Reviews (21 C.F.R. § 820.30(e)):** Failure to