# FDA 483 - Apitoria Pharma Private Limited - December 01, 2025

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/6f5e5d42-b274-40c8-a6ea-1599f903fa48

> FDA 483 for Apitoria Pharma Private Limited on December 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2025-12-01
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Apitoria Pharma Private Limited, a sterile API manufacturer in J.N.Pharamacity, Telangana, India, revealed significant deficiencies in aseptic processing. Observations included inadequate airflow visualization studies for aseptic filling lines, a lack of environmental sampling to support cross-contamination controls, and an aseptic process simulation study that failed to assess worst-case challenge organisms.

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## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/66a8b707-c1e8-4661-8b6c-05923855654c

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3