# FDA 483 - Apitoria Pharma Private Limited - September 27, 2024

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/c88a9780-f209-45af-8216-dbd21e03a3ee

> FDA 483 for Apitoria Pharma Private Limited on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Apitoria Pharma Private Limited in Sanga Reddy District, Telangana, India, revealed ten significant deficiencies in their API manufacturing operations. The observations highlight inadequate equipment maintenance and qualification, insufficient manufacturing instructions and personnel training, and failures in quality unit oversight, water system design, and deviation investigations. These issues collectively indicate a broad lack of adherence to cGMP principles, posing a moderate to severe risk to the quality and integrity of drug substances.

## Related Documents

- [483 - 2016-07-01](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/6f2a3f13-62ed-4024-b141-70e9668fa578)
- [483 - 2019-10-25](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/d9f84278-4c1a-4baf-beae-f2d5ce74b3b1)
- [483 - 2019-10-25](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/c0a8f710-466e-418e-9774-c7f4bef69156)
- [483 - 2024-09-27](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/d70a197d-94fc-49c8-88c7-eb078a386f9f)

## Related Officers

- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)
- [Khalid M. Khan](https://www.keypedia.com/people/khalid-m-khan/fb4bde8b-b17c-4686-b5af-e602c8a46e18)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/3fa64839-667a-4ce5-930b-a1935f0c2b38

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