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 Devices and Radiological Health (CDRH)