FDA 483 - Dr. Reddy's Laboratories, Inc. - May 26, 2022

An FDA inspection of Dr. Reddy's Laboratories, Inc.'s corporate office in Princeton, NJ, revealed two observations related to their Risk Evaluation and Mitigation Strategy (REMS) program. The firm failed to maintain the most updated Medication Guide for buprenorphine and naloxone on their REMS website and did not distribute the REMS Communication Plan according to the required timelines. Additionally, the firm could not provide adequate source documentation to verify the number of REMS letters sent and returned as undeliverable.