FDA Inspection
IntelGenx Corp.IntelGenx Corp. – FDA Inspection, Jan 25, 2019
Record Details
This FDA Inspection record concerns IntelGenx Corp., with an inspection on January 25, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 5aa8b5c2-0f37-4dc6-800e-478733429abf
Inspection Facts
- Inspection number
- 1077109
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of IntelGenx Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2023 | Not classified | Office of Inspections and Investigations | |
| June 14, 2019 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
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