FDA Inspection
fmg Co., Ltd.fmg Co., Ltd. – FDA Inspection, Jul 12, 2019
Record Details
This FDA Inspection record concerns fmg Co., Ltd., with an inspection on July 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8832750e-aacf-4195-b4e2-d71c9953817a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096365
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.122(d)Labels and labeling stored separately
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 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 fmg Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
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