Indoco Remedies Limited — FDA 483 Findings

An -Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.

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

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitably located to facilitate operations for its intended use and cleaning and maintenance.

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

Investigations of an unexplained discrepancy anda 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.