FDA Inspection
Corium Innovations, Inc.Corium Innovations, Inc. – FDA Inspection, Oct 27, 2017
Record Details
This FDA Inspection record concerns Corium Innovations, Inc., with an inspection on October 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Caroline Strasinger (Issuing Officer)
- Charles L. Zhou (FDA Associated Person)
- Matthew B. Casale (FDA Associated Person)
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ID · ee3bdc51-872c-4c3a-8054-244ade82590f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1030335
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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| November 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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