FDA Inspection
IntelGenx Corp.IntelGenx Corp. – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns IntelGenx Corp., with an inspection on June 14, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Ruo H. Xu (Issuing Officer)
- Susan O. Oladeji (FDA Associated Person)
View Company Profile
ID · 74fbd5c9-7838-463d-bca6-c8c0e6ec0025
Inspection Facts
- Inspection number
- 1092982
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
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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 | |
| January 25, 2019 | Not classified | Office of Inspections and Investigations | New Drug Evaluation |
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