# FDA 483 - Apitoria Pharma Private Limited - February 02, 2019

Source: https://www.globalkeysolutions.net/records/483/apitoria-pharma-private-limited/f4589021-5a19-4bd2-b73d-f0e3e1a35012

> FDA 483 for Apitoria Pharma Private Limited on February 02, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2019-02-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Limited, Unit 1, an API manufacturer in Sangareddy, India, was cited for six observations during an FDA inspection. Key issues include inadequate investigations into genotoxic impurities, deficient cleaning process validation, and insufficient process validation for revised manufacturing processes. Additionally, the firm failed to demonstrate proper analytical method validation and transfer, stored production equipment improperly, and used unapproved documents for record-keeping.

## Related Documents

- [483 - 2016-10-25](https://www.globalkeysolutions.net/records/483/apitoria-pharma-private-limited/e96df110-313d-4def-916e-ddaa2b8fbc0f)
- [483 - 2021-08-12](https://www.globalkeysolutions.net/records/483/apitoria-pharma-private-limited/50d3730b-dbcb-4b22-b1b7-71c154f918ed)
- [483 - 2021-08-12](https://www.globalkeysolutions.net/records/483/apitoria-pharma-private-limited/29b3d942-d6ae-4757-ac08-abd02cdeacc1)
- [483 - 2025-08-29](https://www.globalkeysolutions.net/records/483/apitoria-pharma-private-limited/f05b759b-6fe0-4d89-88d1-850416cfcbc2)

## Related Officers

- [Bapu Gaddam](https://www.globalkeysolutions.net/people/bapu-gaddam/1623922f-b2cd-4ba1-94bb-c09ca9a6f838)
- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/apitoria-pharma-private-limited/b761102c-b13d-492c-8dc5-82f2de984faf

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