# FDA 483 - Bajaj Medical, LLC - December 04, 2024

Source: https://www.keypedia.com/records/483/bajaj-medical-llc/d2a595f2-54a6-4f20-b8c2-f1b96bd61e97

> FDA 483 for Bajaj Medical, LLC on December 04, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bajaj Medical, LLC
- Inspection Date: 2024-12-04
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Bajaj Medical, LLC's Corporate Headquarters in Chicago, IL, revealed a significant deficiency in their quality system. The firm failed to develop written procedures for the surveillance, receipt, and evaluation of post-marketing adverse drug experiences. This indicates a critical gap in their ability to monitor and respond to potential safety issues with their products.

## Related Documents

- [483 - 2019-10-01](https://www.keypedia.com/records/483/bajaj-medical-llc/bdb7ccb9-db8f-4cc7-bbb1-69848971a8d0)
- [483 - 2025-08-25](https://www.keypedia.com/records/483/bajaj-medical-llc/f4dec3f1-73c0-4b6c-b569-773621f8e01c)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)

Company: https://www.keypedia.com/companies/bajaj-medical-llc/3aea5c6c-9e94-429d-82a0-594d8f8c666e

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669