Akorn, Inc. — FDA 483 Findings

Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not followed.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation ofthe sterilization process.

Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.

Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.

Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.

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

Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail ofthe methods, equipment, and materials used in the cleaning and maintenance operation, and the methods ofdisassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

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

Routine checking of automatic equipment is not performed according to a written program designed to assure proper performance.

Complaint procedures are deficient in that they do not include provisions that allow for the review to determine ifthe complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.