# FDA 483 - Kathryn Lucas, M.D. - August 27, 2018

Source: https://www.globalkeysolutions.net/records/483/kathryn-lucas-md/b0ab9ff9-a41e-4876-b378-1b96f68aa044

> FDA 483 for Kathryn Lucas, M.D. on August 27, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kathryn Lucas, M.D.
- Inspection Date: 2018-08-27
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Kathryn Lucas, Clinical Investigator, in Morehead City, NC, revealed significant non-compliance with clinical investigational plans and record-keeping. Observations included failures to conduct investigations according to protocol, delayed reporting of serious adverse events, and inadequate maintenance of accurate case histories. These issues indicate a serious lack of adherence to regulatory requirements for clinical trials.

## Related Documents

- [EIR - 2015-05-22](https://www.globalkeysolutions.net/records/eir/kathryn-lucas-md/43363948-0100-4c8f-ab85-c8f7fbbcf5c7)
- [483 - 2015-05-22](https://www.globalkeysolutions.net/records/483/kathryn-lucas-md/bfadf4c8-48de-47ee-ac41-fdc563bbcdb5)
- [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)

## Related Officers

- [Cynthia F Kleinsinger](https://www.globalkeysolutions.net/people/cynthia-f-kleinsinger/9478e17e-2f78-4437-ab3b-4e6927d82a65)
- [Brandy D. Brown](https://www.globalkeysolutions.net/people/brandy-d-brown/667c6b9a-6ab9-42d4-b364-a96207bca072)

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