FDA Inspection
KM PHARMACEUTICAL CO., LTD.KM PHARMACEUTICAL CO., LTD. – FDA Inspection, Feb 22, 2019
Record Details
This FDA Inspection record concerns KM PHARMACEUTICAL CO., LTD., with an inspection on February 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b4062932-a608-4743-8f06-32494aa634dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080318
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(4)Weights and measures of components used
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of KM PHARMACEUTICAL CO., LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2026 | Not classified | Office of Inspections and Investigations |
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