# FDA 483 - Kathryn Lucas, M.D. - April 08, 2016

Source: https://www.globalkeysolutions.net/records/483/kathryn-lucas-md/3342248a-b708-4835-a143-4f8503805302

> FDA 483 for Kathryn Lucas, M.D. on April 08, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kathryn Lucas, M.D.
- Inspection Date: 2016-04-08
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Kathryn J. Lucas, M.D. in Morehead City, NC, identified a significant deviation from the investigational plan for a Type 1 diabetes study. The firm enrolled subjects who did not meet the protocol's eligibility criteria regarding their diabetes diagnosis type and prior medication use. This failure to adhere to the study protocol raises concerns about the integrity of the clinical trial data.

## 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)
- [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

- [Cynthia Kleppinger](https://www.globalkeysolutions.net/people/cynthia-kleppinger/8badb3bc-141f-4094-a02b-b572fdb68fbf)
- [issuing_officer](https://www.globalkeysolutions.net/people/nicole-m-bell/56a038c4-9323-43ac-93d7-0b6911286b73)

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