Company
United StatesGrams Medical Inc., Costa Mesa, CA – FDA Inspections
Inspection records and compliance data for Grams Medical Inc. in Costa Mesa, California. 3 FDA inspections on record (2 OAI), 2 Form 483s, last inspected January 17, 2018.
Company Profile
This profile covers Grams Medical Inc. based in Costa Mesa, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 2
- VAI
- 0
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 25, 2015. Last inspected January 17, 2018.
Most cited issue areas
- DHR content1 inspection
- DMR - not or inadequately maintained1 inspection
- Equipment control activity documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 17, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1038395 |
| November 29, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 998842 |
| September 25, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 942338 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Grams Medical Inc.
FEI Number
2021743
Address
2443 Norse Ave, Costa Mesa, California 92627, United States
Country
United States
ID: b7989b27-bc1c-42ca-a445-04c3d085ed7b