FDA Inspection 1089361 — Susan P. King-Harris, D.P.M.
The FDA completed an inspection of Susan P. King-Harris, D.P.M. on May 9, 2019 in Farmington Hills, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 9, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Farmington Hills, MI (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |