Innovatech Medical Resources L.P. d/b/a Medical Services International (MSI) – FDA Warning Letter, Oct 7, 2011

An FDA inspection of Innovatech Medical Resources, L.P. d/b/a Medical Services International (MSI) in Midlothian, Texas, from September 15 to October 7, 2011, revealed significant violations. MSI, considered a manufacturer due to re-sterilizing and over-labeling medical devices like OPUS Magnum 2 Knotless Fixation devices with extended expiration dates, was found to have adulterated devices.

Key violations of the Quality System regulation (21 CFR Part 820) include: 1. Failure to validate the sterilization cycle used for re-sterilization, lacking biological indicators. 2. Failure to perform design validation for re-sterilized devices and conduct risk analysis for extended expiration dates. 3. Failure to ensure finished devices met original specifications after re-sterilization. 4. Failure to establish procedures for purchasing control and evaluating suppliers like their contract sterilizer. 5. Failure to prevent product damage during handling, evidenced by devices stored above their maximum temperature in a delivery van. 6. Absence of written procedures for corrective and preventive actions. 7. Absence of written procedures for handling complaints. 8. Absence of written quality system procedures. 9. Absence of quality audit procedures.

Additionally, MSI's devices were misbranded due to: - Failure to submit timely reports of corrections and removals (e.g., a recall initiated in August 20