FDA Inspection
The W.S. Badger Company, Inc.The W.S. Badger Company, Inc. – FDA Inspection, Jun 1, 2023
Record Details
This FDA Inspection record concerns The W.S. Badger Company, Inc., with an inspection on June 1, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · af3f101f-90fa-470e-8d37-37e06e4bcdd0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1206814
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
22- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of The W.S. Badger Company, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 14, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 28, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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