FDA 483 - Biocon Biosphere Limited - June 14, 2024
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 Biocon Biosphere Limited in Visakhapatnam, India, revealed significant deficiencies across three observations. The firm failed to establish adequate written procedures for production and process controls, including the use of unqualified equipment and exceeding hold times for in-process materials. Additionally, laboratory controls were found to be lacking scientifically sound test procedures, indicating a potential impact on drug product quality.
ID · 36d2a5cd-e8ac-4ec0-804c-57e8d74c80ef