Ludwig Medical Effingham, IL (8/13). Inspected 5/19-21/03. QSR deviations, adulterated: Firm did not conduct a quality audit since 1991 and did not validate the following processes: gamma irradiation of products labeled as sterile, heat sealer used to seal packages labeled as sterile, and resterilization of products labeled as sterile. Ludwig also failed to establish and maintain procedures for acceptance of incoming product or for implementing corrective and preventive action, etc. (sterile specimen traps); FDCA 501(h), 21CFR 820.22, 820.75(a), 820.70(a), 820.80(b), 820.100(a), 820.30(i), 820.80(d), 820.198(a)(3) (CHI-18-03)
http://www.fda.gov/foi/warning_letters/g4232d.pdf
The First Years, Inc. Avon, MA (8/1). Unapproved new device, adulterated, misbranded. (Natural Comfort breast pump); FDCA 502(o), 510(k), 501(f)(1)(B), 21CFR 807.81(a)(3)(i) (NWE-23-03W)
http://www.fda.gov/foi/warning_letters/g4230d.pdf
Wright Medical Technology Arlington, TN (8/11). Inspected 4/28-5/7/03. QSR deviations, adulterated: Firm shipped a liner 4/17/03 which was manufactured 7/99 prior to the completion of process validation by the Wright’s contract manufacturer for processes such as pressing-green-machining, HIP-sintering, lapping, polishing, laser-engraving, and cleaning. Wright also did not sufficiently evaluate its contract manufacturer to ensure that documentation was available at (purged) to show the supplier could consistently produce the device in accordance with designated specifications, etc. (Transcend Hip System); FDCA 501(h), 21CFR 820.75, 820.50(a) (03-NSV-25)
