FDA Inspection
Intra-Cellular Therapies IncIntra-Cellular Therapies Inc – FDA Inspection, Mar 22, 2019
Record Details
This FDA Inspection record concerns Intra-Cellular Therapies Inc, with an inspection on March 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f11213c2-7c78-4e6e-8d1d-6737675bc2e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085474
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.50Ensuring compliance with plan and protocol
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Other FDA inspections of Intra-Cellular Therapies Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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