FDA Inspection 819580 — Alan W. Heldman
The FDA completed an inspection of Alan W. Heldman on February 15, 2013 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 15, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Miami, FL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2913 | 21 CFR 812.7(b) | Commercialization |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7385 | 21 CFR 50.25(b)(3) | Possible additional costs to the subject |