FDA Inspection
Qualimax LLCQualimax LLC – FDA Inspection, Mar 6, 2013
Record Details
This FDA Inspection record concerns Qualimax LLC, with an inspection on March 6, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Qualimax LLC
- Inspection Date
- March 6, 2013
- Product Type
- Drugs
View Company Profile
ID · 91af472d-f869-4b62-ae31-e303b00066e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820882
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Qualimax LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2016 | NAI | 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 1241221 - 2024-06-13
- FDA Inspection 976571 - 2016-06-24
- FDA Inspection 541636 - 2008-10-08
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