FDA Inspection
Taejoon Pharmaceutical Co., Ltd.Taejoon Pharmaceutical Co., Ltd. – FDA Inspection, Oct 15, 2019
Record Details
This FDA Inspection record concerns Taejoon Pharmaceutical Co., Ltd., with an inspection on October 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 15, 2019
- Product Type
- Drugs
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ID · 125fb7e3-c092-4586-abaa-5795bc47b8de
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1106379
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.165(b)Microbiological testing
- 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 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Taejoon Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2018 | Not classified | Office of Inspections and Investigations | |
| November 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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