# FDA 483 - John M. Kirkwood, MD - October 21, 2024

Source: https://www.globalkeysolutions.net/records/483/john-m-kirkwood-md/3a0b3be9-1790-400d-912e-bb66d88c97b7

> FDA 483 for John M. Kirkwood, MD on October 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John M. Kirkwood, MD
- Inspection Date: 2024-10-21
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of John M. Kirkwood, MD, a clinical investigator in Pittsburgh, revealed significant issues with adherence to investigational plans and maintenance of accurate study records. Specifically, the inspection found failures in collecting and reviewing critical safety lab data and discrepancies in dose administration documentation for subjects. These findings indicate a lack of proper oversight and record-keeping during clinical trials.

## Related Officers

- [D'Arbra R. Blankenship](https://www.globalkeysolutions.net/people/darbra-r-blankenship/d0186717-dbc8-4981-a489-103b781ca92b)

Company: https://www.globalkeysolutions.net/companies/john-m-kirkwood-md/fe0085cd-4b37-44c2-ba07-d1aa198b9925

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8