# FDA 483 - Supriya Lifescience Limited - February 06, 2026

Source: https://www.globalkeysolutions.net/records/483/supriya-lifescience-limited/f8990dae-dd91-4e78-a752-c690c171356d

> FDA 483 for Supriya Lifescience Limited on February 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Supriya Lifescience Limited
- Inspection Date: 2026-02-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: During an FDA inspection from February 2-6, 2026, Supriya Lifescience LTD. in Ratnagiri, India, was cited for failing to demonstrate that its manufacturing process can reproducibly produce intermediates and APIs meeting predetermined quality attributes. This critical issue is highlighted by multiple reprocessed batches and open Out of Specification investigations due to increased impurity levels, indicating significant concerns with process validation and product quality.

## Related Documents

- [483 - 2019-10-03](https://www.globalkeysolutions.net/records/483/supriya-lifescience-limited/7160b7ab-5546-4b80-bb59-ff0b3db2f9c6)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8