Company: Tecan USProduct: Tecan Clinical Workstation and Tecan Genesis RSP Date: 10/8/04 Failure to have complete validation of the _____ software program, as required by 21 CFR 820.30(g). Your firm did not have documentation of complete requirements specifications and software design specification for the entire _____ software program. Documentation of the software program provided by...Read More

Company: Sterex International Ltd..Product: Epilator high frequency needles Date: 10/8/04 Manufacturing equipment, including _____ needle production machines, packaging equipment, and a computerized visual inspection system have not been validated. FDA District: Center for Devices and Radiological Health (CDRH)Read More