FDA Inspection 770157 — Malcolm, Mathew PhD., OTR
The FDA completed an inspection of Malcolm, Mathew PhD., OTR on February 16, 2012 in Fort Collins, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 16, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Fort Collins, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 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 |
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |