# FDA 483 - Apitoria Pharma Private Limited - February 15, 2022

Source: https://www.keypedia.com/records/483/apitoria-pharma-private-limited/a2a96815-dbc8-49f1-8248-8b8f140262e7

> FDA 483 for Apitoria Pharma Private Limited on February 15, 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: 2022-02-15
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Aurobindo Pharma Ltd. (Unit V) in Sangareddy, India, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies in aseptic processing environmental and personnel monitoring, microbiological contamination prevention procedures, and OOS investigations. Additionally, issues were noted with facility design for observation and incomplete batch production records for sterile active pharmaceutical ingredients.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

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

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