# FDA 483 - Althera Laboratories India Private Limited - March 14, 2020

Source: https://www.globalkeysolutions.net/records/483/althera-laboratories-india-private-limited/7fb9ec6a-a300-4180-bd7b-3988b464b427

> FDA 483 for Althera Laboratories India Private Limited on March 14, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Althera Laboratories India Private Limited
- Inspection Date: 2020-03-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Althera Laboratories India Private Limited in Bangalore, India, was cited for significant deficiencies in its method validation laboratory during an FDA inspection. The firm failed to conduct thorough investigations into laboratory discrepancies, maintain adequate documentation for test procedures, and ensure proper controls over computer systems and data accuracy. These issues indicate a lack of robust quality control and data integrity practices.

## Related Officers

- [Rita Kabaso](https://www.globalkeysolutions.net/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)

Company: https://www.globalkeysolutions.net/companies/althera-laboratories-india-private-limited/8ad3abdd-151f-45e8-9802-5d82346f9e1b

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