FDA Inspection
Carlsbad Technology, IncCarlsbad Technology, Inc – FDA Inspection, Apr 24, 2009
Record Details
This FDA Inspection record concerns Carlsbad Technology, Inc, with an inspection on April 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Carlsbad Technology, Inc
- Inspection Date
- April 24, 2009
- Product Type
- Drugs
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ID · eb90dd6d-6869-422e-ab8b-f9712b9eb417
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579393
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(b)Storage conditions
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Carlsbad Technology, Inc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| November 5, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 25, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 4, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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