FDA Inspection
Tai Guk Pharm Co., Ltd., Buyeo branchTai Guk Pharm Co., Ltd., Buyeo branch – FDA Inspection, Jan 20, 2017
Record Details
This FDA Inspection record concerns Tai Guk Pharm Co., Ltd., Buyeo branch, with an inspection on January 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 31de3683-1764-4d2e-81bf-06c71670a6c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004935
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Tai Guk Pharm Co., Ltd., Buyeo branch
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| October 19, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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