# FDA 483 - John M Wo MD - July 23, 2021

Source: https://www.keypedia.com/records/483/john-m-wo-md/fb873aa2-fc24-4a7a-8393-4b9959e075e8

> FDA 483 for John M Wo MD on July 23, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: John M Wo MD
- Inspection Date: 2021-07-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: John M Wo, MD, a Sponsor-Investigator in Indianapolis, IN, was inspected by the FDA from 7/19/2021-7/23/2021. The inspection revealed two significant issues: a failure to maintain adequate case histories for an investigational product, specifically regarding EKG timing, and a lapse in IRB approval for a clinical study. These findings indicate deficiencies in clinical trial conduct and oversight.

## Related Officers

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

Company: https://www.keypedia.com/companies/john-m-wo-md/ca437e94-3739-4f71-bce3-1aa69ceb22ca

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