Lupin Limited – FDA 483, Mar 29, 2023
Lupin Limited in Pithampur, India, received a Form 483 with 10 observations following an inspection from March 21-29, 2023. The observations highlight significant deficiencies in quality control, including inadequate investigations of OOS results and complaints, poor data integrity controls, and insufficient personnel training. The firm also failed to maintain proper environmental controls and sterility assurance for drug products.
ID · 221b0dd1-0d74-4087-b84d-d18d441c876e
Full citation text and observation details available on the Dashboard.
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.