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 established protocol, as required by 21 CFR 820.70(i). For example; the Microsoft 2000 Excel spreadsheet software program was not validated for formulation of reagents and was seen to give incorrect data.
Issuer: Center for Devices and Radiological Health (CDRH)
