# FDA 483 - Apitoria Pharma Private Limited - October 21, 2019

Source: https://www.globalkeysolutions.net/records/483/apitoria-pharma-private-limited/a52b4d24-cefc-44d5-bec4-2c12789effd3

> FDA 483 for Apitoria Pharma Private Limited on October 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apitoria Pharma Private Limited
- Inspection Date: 2019-10-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Aurobindo Pharma Ltd., Unit V, a sterile and non-sterile bulk drug manufacturer, was inspected and cited for four observations. Deficiencies included inadequate laboratory controls for out-of-specification (OOS) results, equipment design issues impacting aseptic operations, insufficient environmental monitoring in aseptic areas, and incomplete process validation for sealing and manufacturing parameters. These issues indicate a lack of robust controls to ensure drug substance quality and sterility.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

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

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