483
Supriya Lifescience LimitedFDA 483 - Supriya Lifescience Limited - October 03, 2019
Record Details
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.
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ID · 7160b7ab-5546-4b80-bb59-ff0b3db2f9c6