# FDA 483 - Supriya Lifescience Limited - October 03, 2019

Source: https://www.globalkeysolutions.net/records/483/supriya-lifescience-limited/7160b7ab-5546-4b80-bb59-ff0b3db2f9c6

> FDA 483 for Supriya Lifescience Limited on October 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Supriya Lifescience Limited
- Inspection Date: 2019-10-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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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## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/supriya-lifescience-limited/62edb654-f16f-4698-aeae-d71ce3abeee2

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1