# FDA 483 - Auriga Research Private Limited - February 06, 2026

Source: https://www.keypedia.com/records/483/auriga-research-private-limited/d4262d5c-bf95-44d0-8ffd-01ee0dc117f8

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

---

## Details

- Record Type: 483
- Company Name: Auriga Research Private Limited
- Inspection Date: 2026-02-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Auriga Research Private Limited, a contract testing laboratory in Bengaluru, India, was cited for significant deficiencies in laboratory controls, data integrity, and quality unit procedures. The inspection revealed failures to document microbiological testing, inadequate investigations into out-of-specification results, and a general lack of adherence to written procedures, indicating systemic issues in quality control.

## Related Documents

- [483 - 2022-07-22](https://www.keypedia.com/records/483/auriga-research-private-limited/1ec56ff0-7420-4dc5-ad83-a5f8d81588b2)

## Related Officers

- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/auriga-research-private-limited/7e7c836f-14d9-4d1e-b965-bafd504f6f12

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