FDA Inspection
4L Health Co., Ltd.4L Health Co., Ltd. – FDA Inspection, Oct 27, 2016
Record Details
This FDA Inspection record concerns 4L Health Co., Ltd., with an inspection on October 27, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 8419aaee-72ea-4fbe-9382-45596030d847
Inspection Facts
- Inspection number
- 1029851
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of 4L Health Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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