FDA Inspection
Schwabe North America, Inc.Schwabe North America, Inc. – FDA Inspection, Feb 17, 2012
Record Details
This FDA Inspection record concerns Schwabe North America, Inc., with an inspection on February 17, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Schwabe North America, Inc.
- Inspection Date
- February 17, 2012
- Product Type
- Drugs
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ID · da446a28-7923-4dfa-8f30-3fd00070dd73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769964
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Schwabe North America, Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2025 | VAI | Minneapolis District Office | Drug Quality Assurance |
| February 19, 2025 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 21, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 20, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2016 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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- FDA Inspection 1157191 - 2021-09-21
- FDA Inspection 1105193 - 2019-08-20
- FDA Inspection 993338 - 2016-11-10
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