# FDA 483 - Jacek Mackiewicz, MD, PhD - April 28, 2023

Source: https://www.globalkeysolutions.net/records/483/jacek-mackiewicz-md-phd/bb4c49d4-d9f9-4060-93ce-b1f894f89860

> FDA 483 for Jacek Mackiewicz, MD, PhD on April 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jacek Mackiewicz, MD, PhD
- Inspection Date: 2023-04-28
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Jacek Mackiewicz, MD, PhD, a clinical investigator in Poznan, Poland, revealed a significant issue regarding the failure to maintain accurate case histories. Specifically, adverse events and concomitant medications for multiple subjects were not reported to the sponsor via case report forms until after the inspection was preannounced. This indicates a serious lapse in data reporting and record-keeping practices during a clinical study.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/craig-a-garmendia/6a17e361-7085-4d55-92b2-37fcaf2f55de)

Company: https://www.globalkeysolutions.net/companies/jacek-mackiewicz-md-phd/3a2e71a0-b588-4467-bc44-e5546036dd57

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4