Alkem Laboratories Limited — FDA 483 Findings

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

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

Deviations from written production and process control procedures are not justified.

There is no written testing program designed to assess the stability characteristics of drug products.

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

Procedures describing the warehousing of drug products are not established and followed.

The quality control unit lacks the responsibility and authority to approve and reject all drug products.

Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.

The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.

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

Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.