FDA Inspection
AMO Puerto Rico Manufacturing, Inc.AMO Puerto Rico Manufacturing, Inc. – FDA Inspection, Nov 28, 2016
Record Details
This FDA Inspection record concerns AMO Puerto Rico Manufacturing, Inc., with an inspection on November 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c314a17f-d050-4cda-bb1a-3a3c83db361c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993515
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of AMO Puerto Rico Manufacturing, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 16, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 26, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 29, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for AMO Puerto Rico Manufacturing, Inc.
- FDA Inspection 1070384 - 2018-10-05
- FDA Inspection 946268 - 2015-10-16
- FDA Inspection 871503 - 2014-03-26
- FDA Inspection 822723 - 2013-02-28
- FDA Inspection 670573 - 2010-06-29
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