# Kathryn J. Lucas, M.D. – FDA 483, Aug 27, 2018

Source: https://www.keypedia.com/records/483/kathryn-j-lucas-md/b0ab9ff9-a41e-4876-b378-1b96f68aa044

> FDA 483 for Kathryn J. 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 J. 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.

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## Related Officers

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

Company: https://www.keypedia.com/companies/kathryn-j-lucas-md/68d4e935-e6f8-40bb-8342-e21633c452f9

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