FDA Inspection
LUMENIS, LTD.LUMENIS, LTD. – FDA Inspection, Feb 2, 2017
Record Details
This FDA Inspection record concerns LUMENIS, LTD., with an inspection on February 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Cynthia L. Gorveatt (Issuing Officer)
- Donna L. Besone (Issuing Officer)
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ID · 7c8969f0-18c7-4384-9475-7c067ed4fe48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001448
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
Showing 10 of 12 citations.
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Other FDA inspections of LUMENIS, LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LUMENIS, LTD.
- FDA Inspection 587390 - 2009-05-28
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