# FDA 483 - Apnar Pharma Private Limited - September 16, 2022

Source: https://www.keypedia.com/records/483/apnar-pharma-private-limited/21970f91-94f2-4c0c-a8bd-3243ea784bde

> FDA 483 for Apnar Pharma Private Limited on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apnar Pharma Private Limited
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Apnar Pharma Private Limited in Vadodara, India, revealed a significant data integrity concern. The firm failed to exercise appropriate controls over computer systems, specifically noting that the FTIR instrument's software lacked audit trail capability. This deficiency impacts the identity testing of finished products and components, indicating a serious lapse in quality control.

## Related Officers

- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.keypedia.com/companies/apnar-pharma-private-limited/14c28e0f-fd47-4c3a-80c3-f85e25d7ea0a

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