FDA Inspection
The W.S. Badger Company, Inc.The W.S. Badger Company, Inc. – FDA Inspection, May 28, 2019
Record Details
This FDA Inspection record concerns The W.S. Badger Company, Inc., with an inspection on May 28, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 28cd4e67-7ab9-40a2-9977-9159f6350788
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1091095
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of The W.S. Badger Company, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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