FDA Inspection
AMO Puerto Rico Manufacturing, Inc.AMO Puerto Rico Manufacturing, Inc. – FDA Inspection, Oct 16, 2015
Record Details
This FDA Inspection record concerns AMO Puerto Rico Manufacturing, Inc., with an inspection on October 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 16, 2015
- Product Type
- Devices
View Company Profile
ID · a9b31846-4342-4375-8149-8f4d2984163a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946268
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
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 |
| November 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 993515 - 2016-11-28
- FDA Inspection 871503 - 2014-03-26
- FDA Inspection 822723 - 2013-02-28
- FDA Inspection 670573 - 2010-06-29
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