FDA Inspection 1032312 — William Philip Werschler, MD, FAAD, FAACS
The FDA completed an inspection of William Philip Werschler, MD, FAAD, FAACS on November 29, 2017 in Spokane, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 29, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Spokane, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2983 | 21 CFR 812.140(a)(2)(iii) | Investigator records of disposition of devices inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |