FDA Inspection 913789 — Lazzaro, Marc, MD
The FDA completed an inspection of Lazzaro, Marc, MD on March 23, 2015 in Milwaukee, WI. 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
- March 23, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Milwaukee, WI (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |