# FDA 483 - Northern Biomedical Research, Inc. - March 29, 2024

Source: https://www.globalkeysolutions.net/records/483/northern-biomedical-research-inc/dde89af9-9736-44c0-b82c-4bcd7dbf5bb8

> FDA 483 for Northern Biomedical Research, Inc. on March 29, 2024. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Northern Biomedical Research, Inc.
- Inspection Date: 2024-03-29
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Northern Biomedical Research, Inc. in Norton Shores, MI, a nonclinical laboratory, received a Form FDA 483 with two observations. The inspection revealed significant issues with inadequate specimen identification and data recording, resulting in numerous instances of mislabeled or switched samples. Additionally, the firm's final study reports failed to include descriptions of all circumstances that could affect data quality, specifically unrecorded protocol deviations regarding sample processing temperatures.

## Related Documents

- [483 - 2021-11-13](https://www.globalkeysolutions.net/records/483/northern-biomedical-research-inc/9ecf5b18-80d6-4f12-937f-3e38db6a0a1e)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)
- [investigator](https://www.globalkeysolutions.net/people/dina-a-tallman/e9bf2b98-6697-4d7c-9052-84339536acfd)

Company: https://www.globalkeysolutions.net/companies/northern-biomedical-research-inc/28aa90cf-580f-4773-8c36-c7d9f9757991

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0