483
Zenara Pharma Pvt LtdFDA 483 - Zenara Pharma Pvt Ltd - May 21, 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.
Record Details
Zenara Pharma Pvt Ltd, a drug manufacturer in Hyderabad, India, was cited for significant deficiencies in its quality systems. Observations included inadequate production and process controls, poorly designed manufacturing equipment leading to yield issues, and a lack of proficiency in data integrity audit trail reviews. The inspection also noted insufficient investigation into out-of-specification dissolution results.
- Office
- Office of Partnerships
- Person
Open in Dashboard
ID · 97ac8e79-7c19-43b9-845c-7adf3824b341