FDA Inspection
Quantum Analytics Group Inc.Quantum Analytics Group Inc. – FDA Inspection, Nov 14, 2011
Record Details
This FDA Inspection record concerns Quantum Analytics Group Inc., with an inspection on November 14, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Quantum Analytics Group Inc.
- Inspection Date
- November 14, 2011
- Product Type
- Drugs
View Company Profile
ID · 74e811fb-7087-4e03-88cb-9941526d3682
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754549
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Quantum Analytics Group Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 19, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 28, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 24, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Quantum Analytics Group Inc.
- FDA Inspection 1276690 - 2025-07-16
- FDA Inspection 1131461 - 2020-09-02
- FDA Inspection 918491 - 2015-03-19
- FDA Inspection 812252 - 2012-12-28
- FDA Inspection 698928 - 2010-11-24
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