Akorn, Inc. — FDA 483 Findings

Written procedures are lacking which describe in sufficient detail the testing, approval, and rejection of components, drug product containers, and closures.

There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Failure to reject any lot of components that did not meet the appropriate written specifications for identity, strength, quality, and purity.

Written production and process control procedw-es are not followed in the execution of production and process control functions.

The master production and control records are deficient in that they do not include complete instructions and specifications.

Each lot of components, drug product containers, and closures is not withheld from usc until the lot has been sampled, tested, examined, and released by the quality control unit.

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

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of usc.