FDA Inspection
LG Electronics, Inc. - Changwon Factory/MWO Div.LG Electronics, Inc. - Changwon Factory/MWO Div. – FDA Inspection, May 12, 2017
Record Details
This FDA Inspection record concerns LG Electronics, Inc. - Changwon Factory/MWO Div., with an inspection on May 12, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 12, 2017
- Product Type
- Medical Devices & Rad Health
- People
- Gregory M. Bessette (Issuing Officer)
- Michael P. Sweeney (Issuing Officer)
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ID · d795a173-e6ff-4e62-80fa-06165dbe8c3a
Inspection Facts
- Inspection number
- 1024287
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(2)(vi)Means to monitor interlocks
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Other FDA inspections of LG Electronics, Inc. - Changwon Factory/MWO Div.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for LG Electronics, Inc. - Changwon Factory/MWO Div.
- FDA Inspection 734273 - 2011-06-10
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