# FDA 483 - V-Ensure Pharma Technologies Pvt. Limited - May 17, 2024

Source: https://www.keypedia.com/records/483/v-ensure-pharma-technologies-pvt-limited/d38bf8f3-655a-4884-bbbc-05a2a84640ce

> FDA 483 for V-Ensure Pharma Technologies Pvt. Limited on May 17, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: V-Ensure Pharma Technologies Pvt. Limited
- Inspection Date: 2024-05-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: V-Ensure Pharma Technologies Pvt. Limited, a drug contract manufacturer, was cited for deficiencies in its stability program. The firm failed to assure that long-term stability samples for a drug product were tested in the same container-closure system as marketed. This deviation from protocol and a prior agency commitment could impact the accuracy of analytical results.

## Related Documents

- [483 - 2023-01-27](https://www.keypedia.com/records/483/v-ensure-pharma-technologies-pvt-limited/f40e8805-b189-49dc-a34c-d7be69837328)

## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/v-ensure-pharma-technologies-pvt-limited/01233430-1062-49f9-ad93-adf95ab293e8

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