FDA Inspection
American Medical Systems InnovationsAmerican Medical Systems Innovations – FDA Inspection, Feb 27, 2018
Record Details
This FDA Inspection record concerns American Medical Systems Innovations, with an inspection on February 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e0bcd051-7e98-43d3-8cce-f6694a4fa4f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042434
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
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Other FDA inspections of American Medical Systems Innovations
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for American Medical Systems Innovations
- FDA Inspection 921183 - 2015-04-03
- FDA Inspection 811690 - 2012-12-21
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