# FDA 483 - Auriga Research Private Limited - July 22, 2022

Source: https://www.keypedia.com/records/483/auriga-research-private-limited/1ec56ff0-7420-4dc5-ad83-a5f8d81588b2

> FDA 483 for Auriga Research Private Limited on July 22, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Auriga Research Private Limited
- Inspection Date: 2022-07-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Auriga Research Private Limited, a contract testing facility in Bengaluru, India, received a Form 483 for significant deficiencies in its quality control unit and equipment design. Observations included inadequate written procedures, poor documentation practices, and lack of verification for critical equipment settings, impacting the integrity of microbial limit testing for drug substance samples. These issues indicate a moderate level of non-compliance with good manufacturing practices.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1