# FDA 483 - ONESOURCE SPECIALTY PHARMA LIMITED - September 01, 2022

Source: https://www.keypedia.com/records/483/onesource-specialty-pharma-limited/0447af6f-e010-4802-b86c-e4eaa5a0deb4

> FDA 483 for ONESOURCE SPECIALTY PHARMA LIMITED on September 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ONESOURCE SPECIALTY PHARMA LIMITED
- Inspection Date: 2022-09-01
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Stelis Biopharma Limited, a combination drug-device manufacturer in Bengaluru, India, revealed significant deficiencies in their quality system. The firm failed to adequately establish and document corrective and preventive action procedures, and did not fully validate equipment and processes for assembling pen injectors. These issues indicate a lack of robust quality control over their manufacturing operations.

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## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/onesource-specialty-pharma-limited/cc051245-e85e-4a66-99ba-4bd9ab31a869

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd