Company
Korea (the Republic of)LG Chem., Ltd., Iksan, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for LG Chem., Ltd. in Iksan. 4 FDA inspections on record (2 OAI), 1 Form 483, last inspected March 29, 2019.
Company Profile
This profile covers LG Chem., Ltd. based in Iksan, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 4, 2010. Last inspected March 29, 2019.
Most cited issue areas
- Investigations of discrepancies, failures1 inspection
- Scientifically sound laboratory controls1 inspection
- Training--operations, GMPs, written procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1088835 |
| June 2, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1012781 |
| October 19, 2012 | OAI | Human Drugs · Drug Quality Assurance | 805926 |
| November 4, 2010 | VAI | Human Drugs · Drug Quality Assurance | 699900 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
LG Chem., Ltd.
FEI Number
3003031339
Address
129 Seogam-Ro, Iksan, Korea (the Republic of)
Country
Korea (the Republic of)
ID: c82fc233-da2e-4a2d-a401-bbf6aa4c232f