# FDA 483 - ONESOURCE SPECIALTY PHARMA LIMITED - March 28, 2025

Source: https://www.globalkeysolutions.net/records/483/onesource-specialty-pharma-limited/9bd2bb77-3188-4c4f-bf85-189380be4b13

> FDA 483 for ONESOURCE SPECIALTY PHARMA LIMITED on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ONESOURCE SPECIALTY PHARMA LIMITED
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: ONESOURCE SPECIALTY PHARMA LIMITED, a sterile drug manufacturer in Bengaluru, India, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed inadequate validation of aseptic processes, including media fills and air flow studies, and a failure to establish robust process control procedures with statistical sampling. Additionally, the firm's intervention procedures for vial filling were incomplete, and its environmental monitoring program did not adequately account for dynamic manufacturing conditions.

## Related Documents

- [483 - 2022-07-19](https://www.globalkeysolutions.net/records/483/onesource-specialty-pharma-limited/e292d2c2-10b3-442e-b3b9-e20011133854)
- [483 - 2022-09-01](https://www.globalkeysolutions.net/records/483/onesource-specialty-pharma-limited/0447af6f-e010-4802-b86c-e4eaa5a0deb4)

## Related Officers

- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

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

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