483
Caplin Steriles LimitedCaplin Steriles Limited – FDA 483, Jun 14, 2019
Record Details
An FDA inspection of Caplin Steriles Limited in Gummidipoondi, India, revealed significant deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm also lacked adequate training for employees performing 100% visual inspection of injectable drug products, raising concerns about product quality and patient safety.
View Company Profile
ID · 1c674607-505f-4a1c-a8c5-24fc7ca4cced
Other documents for Caplin Steriles Limited
- 483 - 2026-08-21
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.