Able Laboratories, Inc. — FDA 483 Findings

Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and followup.

Input to and output from the computer and records or data are not checked for accurac y.

The Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards .

Drug product failing to meet established standards, specifications, and quality control criteria are not rejected.

The quality control units lack authority to fully investigate errors that have occurred.: The Quality Unit and Senior Management failed to assure all drug products distributed have the safety, identity, quality, and purity that they are represented to possess.

Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.

Established laboratory control mechanisms are not followed.

Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations.