Akorn Inc. — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and 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.

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

Appropriate controls are not exercised over computers or related systems to assure that changes in master production an <Redacted B4> control records or other records are instituted only by authorized personnel.

The written stability testing program is not followed.

Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy.

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

Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.

Drug product samples are not properly identified.