FDA Inspection
Lifelines Ltd.Lifelines Ltd. – FDA Inspection, Apr 17, 2018
Record Details
This FDA Inspection record concerns Lifelines Ltd., with an inspection on April 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 66692ac7-b7bd-4e66-b6ad-9bfb89307fe1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048498
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Lifelines Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lifelines Ltd.
- FDA Inspection 925670 - 2015-04-01
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