FDA Inspection
Grams Medical Inc.Grams Medical Inc. – FDA Inspection, Sep 25, 2015
Record Details
This FDA Inspection record concerns Grams Medical Inc., with an inspection on September 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Grams Medical Inc.
- Inspection Date
- September 25, 2015
- Product Type
- Devices
View Company Profile
ID · 2c11d513-0057-4e82-9f4e-190f1da5e6df
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 942338
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| November 29, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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