# FDA 483 - AnaZeal Analyticals & Research Pvt Ltd - February 19, 2025

Source: https://www.keypedia.com/records/483/anazeal-analyticals-research-pvt-ltd/ed414502-5aa8-4e1b-a244-bd67816c8485

> FDA 483 for AnaZeal Analyticals & Research Pvt Ltd on February 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AnaZeal Analyticals & Research Pvt Ltd
- Inspection Date: 2025-02-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: AnaZeal Analyticals & Research Pvt Ltd, a laboratory in Navi Mumbai, India, was inspected by the FDA from February 17-19, 2025. The inspection revealed deficiencies in the firm's quality control unit, specifically concerning incomplete root cause analysis and risk assessment in deviation and complaint investigation reports. This indicates a significant issue with the firm's quality system and its ability to thoroughly investigate and address quality events.

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.keypedia.com/companies/anazeal-analyticals-research-pvt-ltd/c51d1efc-4930-4c44-b742-ae558719304a

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