FDA Inspection
Molnlycke Health Care, IncMolnlycke Health Care, Inc – FDA Inspection, Dec 15, 2016
Record Details
This FDA Inspection record concerns Molnlycke Health Care, Inc, with an inspection on December 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3706e172-4441-4b35-9d75-b2fcb3b1af51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001304
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Molnlycke Health Care, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 14, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Molnlycke Health Care, Inc
- FDA Inspection 739370 - 2011-07-13
- FDA Inspection 576502 - 2009-04-14
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