# FDA 483 - Susan P. King-Harris, D.P.M. - May 09, 2019

Source: https://www.keypedia.com/records/483/susan-p-king-harris-dpm/2301732a-6b96-4c6b-8566-b5d227684741

> FDA 483 for Susan P. King-Harris, D.P.M. on May 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Susan P. King-Harris, D.P.M.
- Inspection Date: 2019-05-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Susan P. King-Harris, D.P.M. in Farmington Hills, MI, revealed significant non-compliance in the conduct of an investigational new drug (IND) trial. The firm failed to adequately monitor the trial, adhere to the investigational plan regarding subject eligibility and drug administration, and obtain proper Institutional Review Board approvals for study changes. Additional violations included failure to secure informed consent, maintain adequate drug disposition records and case histories, and obtain required FDA-1572 forms from investigators.

## Related Documents

- [WARNING_LETTER - 2019-05-09](https://www.keypedia.com/records/warning_letter/susan-p-king-harris-dpm/dbc34f6b-9ac0-4986-a4ce-cb850d84b46b)

## Related Officers

- [Andrace Deyampert](https://www.keypedia.com/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)

Company: https://www.keypedia.com/companies/susan-p-king-harris-dpm/27bdac0a-e12b-4d6e-9a4b-c22b583d9efa

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0