# FDA 483 - Natco Pharma Limited - February 03, 2023

Source: https://www.globalkeysolutions.net/records/483/natco-pharma-limited/5885a052-15bd-471a-bf42-a66c31c14e03

> FDA 483 for Natco Pharma Limited on February 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Natco Pharma Limited
- Inspection Date: 2023-02-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of NATCO Pharma Limited in Visakhapatnam, India, revealed two significant observations. The firm failed to document production and process control procedures at the time of performance, specifically regarding equipment cleaning logbooks. Additionally, investigations into unexplained discrepancies did not extend to other batches of the same drug product, particularly concerning retroactive assessment of impurity testing methods.

## Related Officers

- [Dennis Cantellops Paite](https://www.globalkeysolutions.net/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)
- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/natco-pharma-limited/2684a2f8-36c9-4d09-8a48-2c7f17e0ac7d

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