# FDA 483 - Kathryn Lucas, M.D. - May 22, 2015

Source: https://www.globalkeysolutions.net/records/483/kathryn-lucas-md/bfadf4c8-48de-47ee-ac41-fdc563bbcdb5

> FDA 483 for Kathryn Lucas, M.D. on May 22, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kathryn Lucas, M.D.
- Inspection Date: 2015-05-22
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Kathryn Lucas, M.D. in Morehead City, NC, a clinical investigator, revealed significant deficiencies in conducting an investigation according to the protocol and maintaining adequate case histories. Observations included multiple instances of protocol deviations, such as randomizing subjects with exclusionary readings and failing to follow dosing and rescue therapy procedures. Additionally, there were numerous discrepancies between source documents and eCRFs, with adverse events and concomitant medications not being accurately reported.

## Related Documents

- [EIR - 2015-05-22](https://www.globalkeysolutions.net/records/eir/kathryn-lucas-md/43363948-0100-4c8f-ab85-c8f7fbbcf5c7)
- [EIR - 2016-04-08](https://www.globalkeysolutions.net/records/eir/kathryn-lucas-md/7d077916-1250-4ae7-bf74-03e9de2ebccb)
- [483 - 2016-04-08](https://www.globalkeysolutions.net/records/483/kathryn-lucas-md/3342248a-b708-4835-a143-4f8503805302)
- [EIR - 2018-08-27](https://www.globalkeysolutions.net/records/eir/kathryn-lucas-md/c8be390e-df23-4fd6-b377-d3eb2e29891f)
- [483 - 2018-08-27](https://www.globalkeysolutions.net/records/483/kathryn-lucas-md/b0ab9ff9-a41e-4876-b378-1b96f68aa044)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/eileen-j-bannerman/813432a8-60ce-427f-a0f6-fe6874bc4b59)

Company: https://www.globalkeysolutions.net/companies/kathryn-lucas-md/68d4e935-e6f8-40bb-8342-e21633c452f9

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