FDA Inspection
LG Chem., Ltd.LG Chem., Ltd. – FDA Inspection, Jun 2, 2017
Record Details
This FDA Inspection record concerns LG Chem., Ltd., with an inspection on June 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 59ab85bb-7b6c-4447-8f6a-8d2928a185f7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1012781
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of LG Chem., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 19, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for LG Chem., Ltd.
- FDA Inspection 1088835 - 2019-03-29
- FDA Inspection 805926 - 2012-10-19
- FDA Inspection 699900 - 2010-11-04
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