Company: Advanced Radiation Measurements Inc.
Product: Radiation beam scanners
Date: 3/25/03
Your firm failed to validate processes whose results cannot be fully verified by subsequent inspection and test according to established procedures as required by 21 CFR 820.75. Structural testing conducted as part of your firm’s software validation, and software validation of the Scan Test used to conduct finished product testing was not documented, and your firm failed to validate the Eprom burn-in process (FDA 483, Item #1).
Your firm failed to evaluate and select potential suppliers and contractors on the basis of their ability to meet specified requirements as required by 21 CFR 820.50(a)(1). Your firm failed to assure that your contract electronic manufacturer has appropriate electrostatic discharge (ESD) reduction procedures and appropriate solder process validation (FDA 483, Item #5).
FDA District: Florida District Office
