FDA Inspection
Englewood Lab Korea Co., Ltd.Englewood Lab Korea Co., Ltd. – FDA Inspection, Oct 25, 2024
Record Details
This FDA Inspection record concerns Englewood Lab Korea Co., Ltd., with an inspection on October 25, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · cffa4b92-f427-4a97-b9d1-da37c833a078
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253787
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Englewood Lab Korea Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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