FDA Inspection
Grams Medical Inc.Grams Medical Inc. – FDA Inspection, Jan 17, 2018
Record Details
This FDA Inspection record concerns Grams Medical Inc., with an inspection on January 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shaquenta Y. Perkins (Issuing Officer)
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ID · bf2d079a-5737-4808-a3bd-0f39fe899333
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1038395
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.72(a)Equipment control activity documentation
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Other FDA inspections of Grams Medical Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 25, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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