FDA Inspection 1094514 — Christopher J. Hartnick, MD
The FDA completed an inspection of Christopher J. Hartnick, MD on Jun 28, 2019 in Boston, MA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 28, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Boston, MA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2940 | 21 CFR 812.43(c)(4)(i) | No investigation agreement statement of commitment |
| 2941 | 21 CFR 812.43(c)(4)(ii) | No supervision commitment in investigator agreement |
| 2942 | 21 CFR 812.43(c)(4)(iii) | No informed consent statement in investigator agreement |
| 2944 | 21 CFR 812.43(d) | Monitors not qualified |
| 2992 | 21 CFR 812.140(b)(2) | Sponsor device shipment records inadequate |
| 6849 | 21 CFR 812.5(a) | Label does not contain required information |