Dr. Reddy’s Laboratories Ltd. — FDA 483 Findings

Master production and control records lack sampling and testing procedures.

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

Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.

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

Drains are not provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer.

Adequate lab facilities for testing and approval or rejection of in-process materials and drug products are not available to the quality control unit.

Laboratory controls do not include a determination of conformance to written specifications for in- process materials.

Reserve drug product samples are not representative of each lot or batch of drug product.

The building lacks adequate space for the orderly placement of equipment and materials to prevent mix- ups between drug products and to prevent contamination.

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

The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.