Alkem Laboratories Ltd. — FDA 483 Findings

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

Employees engaged in the manufacture and processing of a drug product lack the traming and experience required to perform their assigned functions.

The in-process control procedures were deficient in that it did not include an examination of tablet and capsule weight variation.

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.

The quality control unit lacks the responsibility and authority to approve and reject all components, in process materials and drug products.

Established laboratory control mechanisms are not documented at the time ofperformance.

All processing lines and major equipment used during the production of a batch of drug product is not properly identified at all times to indicate the phase of processing of the batch.

There is no quality control unit.

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

The written stability testing program is not followed.