FDA Inspection
Schwabe North America, Inc.Schwabe North America, Inc. – FDA Inspection, Dec 3, 2010
Record Details
This FDA Inspection record concerns Schwabe North America, Inc., with an inspection on December 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Schwabe North America, Inc.
- Inspection Date
- December 3, 2010
- Product Type
- Drugs
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ID · f8c3819d-3075-4e28-987f-9317d41d0b4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702650
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 111.560(a)(1)Product complaint - quality control review
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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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 |
Other documents for Schwabe North America, Inc.
- FDA Inspection 1271627 - 2025-08-28
- FDA Inspection 1253920 - 2025-02-19
- FDA Inspection 1157191 - 2021-09-21
- FDA Inspection 1105193 - 2019-08-20
- FDA Inspection 993338 - 2016-11-10
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