FDA Inspection
Apex Pharmaceuticals Inc.Apex Pharmaceuticals Inc. – FDA Inspection, Apr 18, 2019
Record Details
This FDA Inspection record concerns Apex Pharmaceuticals Inc., with an inspection on April 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · acd2cd41-87e3-4b8f-ae9f-2ba918d9aa96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086635
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Apex Pharmaceuticals Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2016 | Not classified | New Jersey District Office |
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