FDA Inspection
AMO Puerto Rico Manufacturing, Inc.AMO Puerto Rico Manufacturing, Inc. – FDA Inspection, Mar 11, 2010
Record Details
This FDA Inspection record concerns AMO Puerto Rico Manufacturing, Inc., with an inspection on March 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 11, 2010
- Product Type
- Devices
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ID · eb579471-a18a-4345-b405-0ddb26241ba4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652088
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)General
- 21 CFR 820.198(e)(7)Corrective action taken
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| 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 |
Other documents for AMO Puerto Rico Manufacturing, Inc.
- FDA Inspection 1070384 - 2018-10-05
- FDA Inspection 993515 - 2016-11-28
- FDA Inspection 946268 - 2015-10-16
- FDA Inspection 871503 - 2014-03-26
- FDA Inspection 822723 - 2013-02-28
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