# FDA 483 - Marc A. Bjurlin, D.O. - July 22, 2024

Source: https://www.globalkeysolutions.net/records/483/marc-a-bjurlin-do/cb90fa63-c351-4bd7-8a63-7d2f01bbe498

> FDA 483 for Marc A. Bjurlin, D.O. on July 22, 2024. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marc A. Bjurlin, D.O.
- Inspection Date: 2024-07-22
- Product Type: devices
- Office Name: Atlanta District Office
- Summary: During an inspection conducted from July 15 to July 22, 2024, the Food and Drug Administration (FDA) issued a Form 483 to Clinical Investigator Marc A. Bjurlin, D.O., operating at UNC Hospitals Urology Clinic in Chapel Hill, NC. The inspection identified a significant deviation from regulatory expectations concerning the conduct of a specific clinical study, Protocol Study (b)(4). The primary observation noted was that the investigation was not carried out in accordance with the agreed-upon study protocol and the investigator's commitments. Specifically, the FDA found that essential, protocol-required imaging assessments for enrolled subjects were not performed. These missed assessments included two distinct imaging procedures, as outlined in Section 9.1.4.1. of the study protocol. This represents a failure to adhere to the established investigational plan. The FDA 483 document serves as a record of these inspectional observations, highlighting areas where the clinical trial conduct did not meet federal regulations. While not a final determination of compliance, it requires the investigator to consider corrective actions or provide a response addressing these deficiencies to ensure the ethical and scientific rigor of ongoing and future clinical research.

## Related Officers

- [D.O.](https://www.globalkeysolutions.net/people/marc-a-bjurlin/82e98b56-e1b0-44bf-b4e6-8d2268c5a7f8)
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Company: https://www.globalkeysolutions.net/companies/marc-a-bjurlin-do/376464a1-4d83-4cb3-a9a7-d942d21a7d21

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7