FDA 483 - Dr. Reddy's Laboratories Ltd. - April 28, 2017

This FDA Form 483 details multiple deficiencies observed during an inspection, indicating significant issues with laboratory controls, data integrity, quality unit authority, personnel qualifications, and equipment maintenance.

Key violations include: * **Laboratory Controls:** Absence of scientifically sound sampling plans for in-process materials and drug products, leading to inadequate assurance of identity, strength, quality, and purity. Laboratory records are incomplete, lacking full data from testing. * **Data Integrity:** Backup data is not assured as exact, complete, or secure from alteration, erasure, or loss. * **Product Release:** Drug products are released for distribution without appropriate laboratory determination of conformance to final specifications. * **Quality Control Unit:** The quality control unit's responsibilities and procedures are not fully followed, and it lacks the authority to fully investigate errors. * **Equipment Maintenance:** Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment are not performed according to a written program. * **Personnel Qualifications:** Individuals supervising manufacturing and processing, as well as employees engaged in these activities, lack the necessary education, training, and experience to assure product safety, identity, strength, quality, and purity. * **Supplier Reliability:** The reliability of component suppliers' reports of analyses is deficient, with test results not appropriately validated at intervals. * **Reserve Samples:** Reserve samples are not visually examined annually for deterioration.

These observations suggest systemic failures in the