# FDA 483 - Bajaj Medical, LLC - August 25, 2025

Source: https://www.keypedia.com/records/483/bajaj-medical-llc/f4dec3f1-73c0-4b6c-b569-773621f8e01c

> FDA 483 for Bajaj Medical, LLC on August 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bajaj Medical, LLC
- Inspection Date: 2025-08-25
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Bajaj Medical, LLC, a drug manufacturer in Chicago, IL, was cited for deficiencies in its raw material sampling plans. The firm failed to provide scientifically rigorous justification for its sampling methods for critical ingredients like propylene glycol, glycerin, and Specially Denatured Alcohol, particularly concerning global supply chain integrity issues. This could impact the quality and safety of their orally ingested drug products and oral rinses.

## Related Documents

- [483 - 2019-10-01](https://www.keypedia.com/records/483/bajaj-medical-llc/bdb7ccb9-db8f-4cc7-bbb1-69848971a8d0)
- [483 - 2024-12-04](https://www.keypedia.com/records/483/bajaj-medical-llc/d2a595f2-54a6-4f20-b8c2-f1b96bd61e97)

## Related Officers

- [Tyler M. Peterson](https://www.keypedia.com/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)

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