# Apitoria Pharma Private Limited – FDA 483, May 10, 2024

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/ae36b84b-ad18-4b2e-9588-3fe277720017

> FDA 483 for Apitoria Pharma Private Limited on May 10, 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: 2024-05-10
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: The FDA inspected Apitoria Pharma Private Limited Unit VII in Parawada Mandal, India, from May 6-10, 2024. The inspection revealed significant deficiencies in quality control, specifically regarding the testing and approval of starting materials and drug substances for identity, quality, and purity. These issues led to the release of non-sterile drug substance lots without proper impurity identification and control, indicating a serious lapse in manufacturing oversight.

## Related Officers

- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/7797eab5-3d0a-4af9-a8ca-d75b2b0085f6

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