FDA Inspection
LG Electronics Inc.LG Electronics Inc. – FDA Inspection, May 10, 2017
Record Details
This FDA Inspection record concerns LG Electronics Inc., with an inspection on May 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Gregory M. Bessette (Issuing Officer)
- Michael P. Sweeney (Issuing Officer)
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ID · 8bc781d0-5966-4fb7-ab6a-aa902523b6ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024289
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1030.10(c)(2)(vi)Means to monitor interlocks
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
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Other FDA inspections of LG Electronics Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2024 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 10, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 24, 2015 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| May 18, 2010 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for LG Electronics Inc.
- FDA Inspection 1259899 - 2024-11-07
- FDA Inspection 1102759 - 2019-06-10
- FDA Inspection 935021 - 2015-06-24
- FDA Inspection 666785 - 2010-05-18
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