FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - April 04, 2017

This FDA Form 483 details observations from an inspection, citing two primary issues related to laboratory control and record-keeping.

Firstly, the facility failed to maintain complete records for periodic calibration of laboratory instruments. Specifically, for High Performance Liquid Chromatography (HPLC) systems, the firm did not monitor the lamp hours of their UV detectors. The QC laboratory's HPLC units lacked periodic checks of UV-Vis lamps after 2000 hours of operation, contrary to manufacturer recommendations. Examples include six HPLC units (QC-170, QC-169, QC-024, QC-026, QC-122, QC-021) with operational hours ranging from 2,371 to 13,003 hours, without lamp replacement or reset.

Secondly, laboratory records did not include a complete record of all data from each test, specifically lacking HPLC standard and sample chromatograms. For instance, laboratory records for (b)(4) USP Batch #(b)(4) (manufactured 2/25/2017), (b)(4) (manufactured 2/23/2017), and (b)(4) (manufactured 2/22/2017) only contained results summary reports for Assay and Related Substances, with chromatographic data limited to calculated results for the last three months. These observations indicate deficiencies in the firm's quality system