FDA 483 - Dr. Reddy's Laboratories, Inc. - May 26, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · fe22d74f-f3b5-421b-bea0-b89f9cd48c63