# FDA 483 - Apitoria Pharma Private Limited - December 17, 2024

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/d3d1e57d-fbf0-4284-8804-4a4b14ac22c8

> FDA 483 for Apitoria Pharma Private Limited on December 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2024-12-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Aptoria Pharma Private Limited, Unit-V, located in Patancheru Mandal, India, received an FDA Form 483 citing significant deficiencies. The inspection revealed inadequate validation of aseptic processes for sterile drug substances, including issues with media fill studies and disinfectant efficacy. Additionally, the firm failed to conduct annual visual examinations of reserve samples for deterioration.

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## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

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

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