FDA Inspection
Taejoon Pharmaceutical Co., Ltd.Taejoon Pharmaceutical Co., Ltd. – FDA Inspection, Nov 15, 2016
Record Details
This FDA Inspection record concerns Taejoon Pharmaceutical Co., Ltd., with an inspection on November 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 46ed1b67-b0d8-400c-be70-4f414f51eb95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994512
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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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 |
| October 15, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2018 | Not classified | Office of Inspections and Investigations |
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