# FDA 483 - Apitoria Pharma Private Limited - November 18, 2022

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/0ca5c5f3-e631-4d6e-81ed-de043814efd9

> FDA 483 for Apitoria Pharma Private Limited on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2022-11-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of Aurobindo Pharma Limited Unit IX revealed significant deficiencies across multiple areas of its API intermediate manufacturing. The firm's investigations into Out of Specification results and market complaints were found to be scientifically unsound and incomplete. Furthermore, critical processes such as process validation, analytical method validation, equipment cleaning validation, and laboratory control mechanisms, including data integrity, were all deemed inadequate.

## Related Documents

- [483 - 2019-02-02](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/413edfc9-6cdb-41b0-851f-7ffd80aed504)
- [483 - 2022-11-18](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/ba1f804a-59c7-4d63-85c1-0e869b77a78c)

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Arsen Karapetyan](https://www.keypedia.com/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/7a543877-97f7-4c4a-8dc8-74ee9d1c0caf

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