# FDA 483 - Apitoria Pharma Private Limited - August 01, 2022

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/a74f3cff-2b7b-49cd-b3b8-759a5b3ea22d

> FDA 483 for Apitoria Pharma Private Limited on August 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2022-08-01
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: The FDA inspected Aurobindo Pharma Limited, Unit XI, an API manufacturer in Pydibhimavaram, India, revealing significant quality system deficiencies. Observations included inadequate equipment cleaning procedures leading to visible residue and rust, a failure to thoroughly investigate numerous instrument errors and a market complaint, and a lack of adherence to quality control unit procedures for deviation initiation and contemporaneous data recording. These issues indicate a concerning lack of control over manufacturing processes and quality systems.

## Related Documents

- [483 - 2019-02-09](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/f8d8e483-5470-4fee-93e1-91c722ed13b5)
- [483 - 2022-08-02](https://www.keypedia.com/records/483/apitoria-pharma-private-limited/b0edad77-410b-447f-9b78-9ab60e46d25b)

## Related Officers

- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)
- [Jeffrey D. Rauschmeier](https://www.keypedia.com/people/jeffrey-d-rauschmeier/d4afaa73-abac-46ba-bfb8-623d9d655617)

Company: https://www.keypedia.com/companies/apitoria-pharma-private-limited/c56154eb-1a77-4f64-9db0-4ae380d6b65e

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4