Company: IND Diagnostic Inc.Product: Medical device Date: 12/23/03 Failure to establish and maintain procedures to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results as required by 21 CFR 820.72 (a). Issuer: Center for...Read More

Company: Eldon Biologicals A/S.Product: Medical device Date: 12/23/03 Microsoft 2000 Excel spreadsheet software used manufacturing has not been validated for the purpose of generating a worksheet for formulation of reagents. No documentation was found to establish or verify corrections made to the program. Failure to validate computer software for its intended use according to an...Read More