FDA 483 - Dr Reddy's Laboratories Limited - December 08, 2023

This FDA Form 483 document details deficiencies observed during an inspection related to laboratory records, data integrity, and employee training.

**Facility and Operation Details:** The inspection pertains to a facility producing (b)(4) Injection and (b)(4) API. The firm conducted a sameness study for (b)(4) Injection to compare it to a Reference Listed Drug (RLD) using Circular Dichroism Spectropolarimeter (equipment ID: AA266) and Nuclear Magnetic Resonance Spectrometer (NMR, equipment ID: AA574).

**Violations and Observations:** * **Deficient Laboratory Records:** Laboratory records for the sameness study of (b)(4) Injection were found to be deficient, lacking complete and accurate data. * **Omitted and Unreported Electronic Data:** * An initial Circular Dichroism spectra scan for Test Drug batch (b)(4) on 11/25/2016, created at (b)(4), was omitted from analysis. A second scan was reported instead, and a temperature fluctuation incident was not investigated or reported to the agency. * Circular Dichroism data for RLD batch #(b)(4) and Test Drug batch (b)(4) generated on 11/28-29/2016 was not reported and invalidated without scientific justification. A Laboratory Investigation Report (LIR-A-AD