Dr. Reddy's Laboratories — FDA 483 Findings

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

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

Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Individuals responsible for supervising the manufacture and processing of a drug product lack the education, training and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.

Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least for evidence of deterioration.

The quality control unit lacks authority to fully investigate errors that have occurred.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.