FDA 483 - Supriya Lifescience Limited - October 03, 2019
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 Supriya Lifescience Ltd. in Ratnagiri, India, revealed seven significant observations regarding their API manufacturing processes. The firm demonstrated a lack of adequate cleaning and process validation, insufficient risk analysis, and poor quality unit oversight. Additionally, deficiencies were noted in equipment maintenance, record-keeping practices, and the storage of reserve and stability samples, indicating a need for comprehensive corrective actions.
ID · 7160b7ab-5546-4b80-bb59-ff0b3db2f9c6