# FDA 483 - V-Ensure Pharma Technologies Pvt. Limited - January 27, 2023

Source: https://www.keypedia.com/records/483/v-ensure-pharma-technologies-pvt-limited/f40e8805-b189-49dc-a34c-d7be69837328

> FDA 483 for V-Ensure Pharma Technologies Pvt. Limited on January 27, 2023. 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: 2023-01-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: V-Ensure Pharma Technologies Pvt. Limited in Raigad, India, was issued a Form 483 following an FDA inspection from January 23-27, 2023. The inspection revealed a significant quality system deficiency related to the firm's failure to investigate and document unexplained discrepancies in manufacturing records. This indicates a serious lapse in the firm's quality control and record-keeping practices for drug manufacturing.

## Related Documents

- [483 - 2024-05-17](https://www.keypedia.com/records/483/v-ensure-pharma-technologies-pvt-limited/d38bf8f3-655a-4884-bbbc-05a2a84640ce)

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

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