FDA Inspection
Aekyung Industrial Co. Ltd.Aekyung Industrial Co. Ltd. – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns Aekyung Industrial Co. Ltd., with an inspection on November 17, 2023, issued by the Office of Inspections and Investigations.
- Company
- Aekyung Industrial Co. Ltd.
- Inspection Date
- November 17, 2023
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ID · 7382569e-05ad-44b7-9e64-32dc856b636f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223616
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Aekyung Industrial Co. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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