FDA Inspection
9338-9641 Quebec Inc.9338-9641 Quebec Inc. – FDA Inspection, Mar 14, 2025
Record Details
This FDA Inspection record concerns 9338-9641 Quebec Inc., with an inspection on March 14, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 7ff4741d-5ca3-4165-91b1-489f401680ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1261259
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of 9338-9641 Quebec Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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