# FDA 483 - Christine H. Lee, M.D. - June 17, 2022

Source: https://www.keypedia.com/records/483/christine-h-lee-md/9fd01823-7df8-430e-af07-68d413691b82

> FDA 483 for Christine H. Lee, M.D. on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Christine H. Lee, M.D.
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted at Christine H. Lee, M.D., from June 6 to June 17, 2022, identified significant deviations from regulatory requirements for clinical investigations. The observations primarily concern the conduct of two investigational new drug studies, 2014-01 and 2017-01. The main violations centered on the failure to conduct investigations in accordance with the signed investigator statement and investigational plan. Specifically, the firm enrolled and dosed subjects who did not meet all eligibility criteria, such as lacking proper documentation for C. difficile infection timing or not meeting the protocol definition of recurrent C. difficile infection. Additionally, informed consent was improperly obtained from legally authorized representatives for subjects who, per protocol, were required to provide their own consent. Other issues included a dosing error where a subject received the wrong batch of study drug, failure to collect required stool samples when C. difficile reoccurrence was suspected, and dosing a subject without adhering to a mandated antibiotic washout period. The inspection also noted a failure to prepare and maintain adequate case histories, exemplified by a lack of adverse event assessment documentation for a hospitalized study participant. These observations indicate a need for corrective actions to ensure compliance with federal regulations governing clinical trials, particularly regarding subject protection, protocol adherence, and accurate record-keeping.

## Related Documents

- [483 - 2022-06-17](https://www.keypedia.com/records/483/christine-h-lee-md/7fc44400-715b-4f26-9dcd-ab637fca10ab)

## Related Officers

- [investigator](https://www.keypedia.com/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.keypedia.com/companies/christine-h-lee-md/ff898326-9ab7-4806-9c36-ab29cb8d5176

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa