FDA Inspection
Aekyung Industrial Co. Ltd.Aekyung Industrial Co. Ltd. – FDA Inspection, Sep 3, 2015
Record Details
This FDA Inspection record concerns Aekyung Industrial Co. Ltd., with an inspection on September 3, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aekyung Industrial Co. Ltd.
- Inspection Date
- September 3, 2015
- Product Type
- Drugs
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ID · caa2e5f2-b367-4009-ada4-722a1be93c43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 942541
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
Showing 10 of 11 citations.
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Other FDA inspections of Aekyung Industrial Co. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | VAI | Office of Inspections and Investigations |
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