Company: Gensia Sicor Pharmaceuticals Inc.
Product: Drug Products
Failure to maintain laboratory records to include complete data derived from all tests necessary to assure compliance with established specifications and standards [21 CFR 211.194]. Specifically, your firm failed to properly maintain electronic files containing data secured in the course of tests from 20 HPLCs and 3 GLCs. Additionally, no investigation was conducted by your company to determine the cause of missing data and no corrective measures were implemented to prevent the recurrence of this event.
FDA District: Irvine, CA