# FDA 483 - Natco Pharma Ltd. - Chemical Division - August 09, 2019

Source: https://www.globalkeysolutions.net/records/483/natco-pharma-ltd-chemical-division/5ea9e86e-9e64-446e-9b6b-764431d2ed8b

> FDA 483 for Natco Pharma Ltd. - Chemical Division on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Natco Pharma Ltd. - Chemical Division
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Natco Pharma Limited, an Active Pharmaceutical Ingredients manufacturer in Rangareddy District, India, revealed significant deficiencies across multiple quality systems. Observations included inadequate quality control procedures, insufficient employee training, lack of process revalidation after critical changes, and poor equipment cleaning and maintenance. Additionally, issues with computer system controls and laboratory practices for microbial testing were noted, indicating a broad failure to ensure product quality and purity.

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/natco-pharma-ltd-chemical-division/3d56c2ac-4a7d-4f9f-8987-966d0ff5e5f1

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