Company
United StatesColumbia Scientific Development LLC, Portland, OR – FDA Inspections
Inspection records and compliance data for Columbia Scientific Development LLC in Portland, Oregon. 3 FDA inspections on record, 1 Form 483, last inspected June 07, 2017.
Company Profile
This profile covers Columbia Scientific Development LLC based in Portland, Oregon, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 18, 2016. Last inspected June 7, 2017.
Most cited issue areas
- Design history file1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 7, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1013301 |
| May 18, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 973833 |
| May 18, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 973831 |
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
Columbia Scientific Development LLC
FEI Number
3012321270
Address
650 Ne Holladay St Ste 1600, Portland, Oregon 97232, United States
Country
United States
ID: c99634d0-bef8-417d-83d7-de53b41ae07c