FDA Inspection
Qualimax LLCQualimax LLC – FDA Inspection, Jun 13, 2024
Record Details
This FDA Inspection record concerns Qualimax LLC, with an inspection on June 13, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b677da20-e9fa-43bf-a3a8-0d3e53b5f2c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1241221
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Qualimax LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 8, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Qualimax LLC
- FDA Inspection 976571 - 2016-06-24
- FDA Inspection 820882 - 2013-03-06
- FDA Inspection 541636 - 2008-10-08
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