483
Zydus Lifesciences LimitedFDA 483 - Zydus Lifesciences Limited - March 10, 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.
Record Details
An FDA inspection of Cadila Healthcare Limited, a sterile drug manufacturer in Jarod, Gujarat, India, revealed significant deficiencies. The firm failed to adhere to its written stability testing program and did not complete Annual Product Quality Reviews within established timelines. Additionally, the compounding room for sterile injectable drugs was not maintained in a good state of repair, presenting a potential contamination risk.
Open in Dashboard
ID · 675c200e-79d4-4064-b3af-9026f3ff369b