FDA Inspection
Carma Laboratories, Inc.Carma Laboratories, Inc. – FDA Inspection, Nov 27, 2012
Record Details
This FDA Inspection record concerns Carma Laboratories, Inc., with an inspection on November 27, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Carma Laboratories, Inc.
- Inspection Date
- November 27, 2012
- Product Type
- Drugs
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ID · 6af8dd7f-355a-4d81-9307-d979589c63ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808711
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Carma Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Carma Laboratories, Inc.
- FDA Inspection 1223668 - 2023-11-14
- FDA Inspection 984836 - 2016-08-24
- FDA Inspection 653056 - 2010-03-30
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