FDA Inspection
Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) – FDA Inspection, Aug 24, 2022
Record Details
This FDA Inspection record concerns Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory), with an inspection on August 24, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 24, 2022
- Product Type
- Drugs
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ID · c1c9c9fa-b993-41ec-b91e-32cad14de631
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1179508
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 15, 2024 | Not classified | Office of Inspections and Investigations | |
| November 17, 2017 | Not classified | Office of Inspections and Investigations |
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