FDA 483 - Dr. Reddy's Laboratories Limited - March 05, 2020

On March 1-5, 2020, the FDA inspected Dr. Reddy's Laboratories Ltd. - CTO 5, an API Manufacturer in Nalgonda, Telangana, India. The inspection, led by Christopher Keating and Tomika L. Bivens, identified several observations.

Under the Production System, the facility's system for reprocessing APIs and API intermediates was deemed insufficient. Specifically, reprocessed batches of (b)(4) API and intermediates were not uniquely identified, lacking distinct material or batch numbers. Furthermore, (b)(4) API reprocessing process validation and commercially reprocessed lots were not adequately placed on stability monitoring to ensure consistent quality attributes per USP monograph criteria throughout the shelf life of APIs manufactured using reprocessed materials. The firm's procedure for skip testing allowed reduced testing for previously rejected and reprocessed batches of (b)(4) API and intermediate without appropriate justification.

Within the Laboratory System, retest periods for reference standards used in QC laboratory analysis of APIs and API intermediates were not supported by analytical data. The effective shelf lives of third-party supplied reference standards for (b)(4) API and API-impurity were not validated, with the specified (b)(4) retest period lacking supporting studies. Additionally, laboratory equipment, specifically HPLC columns used for release testing of (b)(4) USP API, were not adequately maintained or qualified. The firm's QC manager indicated a second analytical method was created due to "poor column performance