Company
United StatesAcumed LLC, Hillsboro, OR – FDA Inspections
Inspection records and compliance data for Acumed LLC in Hillsboro, Oregon. 4 FDA inspections on record, 1 Form 483, last inspected May 11, 2017.
Company Profile
This profile covers Acumed LLC based in Hillsboro, Oregon, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected August 25, 2009. Last inspected May 11, 2017.
Most cited issue areas
- Maintenance schedule, Lack of or inadequate schedule1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
- Reporting Information Reasonably Known1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 11, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1015903 |
| June 26, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 838475 |
| July 27, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 736552 |
| August 25, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 606927 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Acumed LLC
FEI Number
1000125930
Address
5885 NW Cornelius Pass Rd, Hillsboro, Oregon 97124, United States
Country
United States
ID: eed27890-e051-4efc-b4b2-5aaa465898d9