# FDA 483 - Aragen Life Sciences Limited - January 23, 2026

Source: https://www.globalkeysolutions.net/records/483/aragen-life-sciences-limited/ba835e78-9074-4ce7-9adc-516a2a93d76d

> FDA 483 for Aragen Life Sciences Limited on January 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aragen Life Sciences Limited
- Inspection Date: 2026-01-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: This FDA Form 483 was issued to Aragen Life Sciences Limited in Hyderabad, India, an active pharmaceutical ingredient manufacturer, following an inspection from January 19-23, 2026. The inspection revealed significant deficiencies in equipment cleaning and maintenance, inadequate written procedures for production and process controls, and a failure to thoroughly investigate batch discrepancies and out-of-specification results. These findings indicate a lack of control over critical manufacturing processes that could impact drug substance quality.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.globalkeysolutions.net/companies/aragen-life-sciences-limited/7d982e4a-6c1e-474c-b5c8-0a0286628be7

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