# FDA 483 - Michael C. Heinrich, M.D. - August 16, 2019

Source: https://www.globalkeysolutions.net/records/483/michael-c-heinrich-md/806fd280-0fb5-4a08-aec2-f67a63d42ca9

> FDA 483 for Michael C. Heinrich, M.D. on August 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michael C. Heinrich, M.D.
- Inspection Date: 2019-08-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Michael C. Heinrich, M.D. in Portland, OR, a clinical investigator, revealed significant deficiencies in clinical trial conduct. Observations included failures to ensure informed consent was understandable for non-English speaking subjects and deviations from the investigational plan. These deviations involved enrolling a subject with exclusionary criteria and missing required ECG assessments, indicating a lack of adherence to regulatory requirements for human subject protection and study integrity.

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Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822