# FDA 483 - Brian B. Borg, M.D. - September 01, 2023

Source: https://www.keypedia.com/records/483/brian-b-borg-md/26213ebf-ae54-4bb0-bcd4-a1415e5484df

> FDA 483 for Brian B. Borg, M.D. on September 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brian B. Borg, M.D.
- Inspection Date: 2023-09-01
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: An FDA inspection conducted at Brian B. Borg, M.D., from August 28 to September 1, 2023, identified significant deviations in the conduct of a clinical investigation. The observations, detailed in a Form FDA 483, indicate a lack of adherence to the signed investigator statement and investigational plan. The primary issues revolved around investigational product (IP) administration and protocol compliance. Specifically, three out of five study subjects received investigational product that did not match their randomization assignments, with one instance linked to an adverse event of bloating and diarrhea. Furthermore, the sub-investigator failed to adhere to the protocol-defined infusion times for all five subjects, with durations varying substantially from specified parameters. A second critical observation concerned investigational drug accountability. Original records documenting the quantity and use of the investigational product by subjects were either unavailable or not provided during the inspection, highlighting inadequate record-keeping practices. These observations signify non-compliance with regulatory requirements governing clinical trials, particularly concerning subject safety and data integrity, under the Federal Food, Drug and Cosmetic Act. Brian B. Borg, M.D., is expected to evaluate these findings and implement comprehensive corrective actions to address the identified deficiencies and ensure future adherence to regulatory standards and study protocols.

## Related Documents

- [483 - 2023-09-01](https://www.keypedia.com/records/483/brian-b-borg-md/59f58a2f-aa0c-41af-b428-45c3a2a4840f)

## Related Officers

- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)
- [investigator](https://www.keypedia.com/people/kellie-r-riggs/556818c6-eb9a-48a5-9630-aba7a807ec07)

Company: https://www.keypedia.com/companies/brian-b-borg-md/ea7e9c31-dcb5-4bda-ba65-737b097e5571

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516