FDA Inspection
Joyce M. Slingerland, M.D., Ph.D., F.R.C.P. (C)FDA Inspection 967960 - Joyce M. Slingerland, M.D., Ph.D., F.R.C.P. (C) - March 24, 2016
Record Details
This FDA Inspection record concerns Joyce M. Slingerland, M.D., Ph.D., F.R.C.P. (C), with an inspection on March 24, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 24, 2016
- Product Type
- Drugs
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ID · e5eda2f7-bf06-4a11-aac1-f0b210239a17
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 967960
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 312.56(b)Investigator non-compliance
- 21 CFR 312.50Ensuring compliance with plan and protocol
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 50.27(b)(2)Short form: Summary copy not signed/given
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Joyce M. Slingerland, M.D., Ph.D., F.R.C.P. (C)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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