FDA Inspection
Grams Medical Inc.Grams Medical Inc. – FDA Inspection, Nov 29, 2016
Record Details
This FDA Inspection record concerns Grams Medical Inc., with an inspection on November 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b81a0b9a-1da7-4189-9917-0b2ab84fa3ac
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 998842
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Grams Medical Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 25, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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