FDA Inspection 967960 — Joyce M. Slingerland, M.D., Ph.D., F.R.C.P. (C)
The FDA completed an inspection of Joyce M. Slingerland, M.D., Ph.D., F.R.C.P. (C) on March 24, 2016 in Miami, FL. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 24, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Miami, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7381 | 21 CFR 50.27(b)(2) | Short form: Summary copy not signed/given |
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |