Company
United StatesACUTE Innovations LLC, Hillsboro, OR – FDA Inspections
Inspection records and compliance data for ACUTE Innovations LLC in Hillsboro, Oregon. 4 FDA inspections on record, last inspected January 28, 2016.
Company Profile
This profile covers ACUTE Innovations LLC based in Hillsboro, Oregon, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 19, 2010. Last inspected January 28, 2016.
Most cited issue areas
- Complaints1 inspection
- Design plans - Lack of or inadequate1 inspection
- Incorrect translation to production specifications1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 954923 |
| April 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 828035 |
| October 21, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 752065 |
| August 19, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 676409 |
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
ACUTE Innovations LLC
FEI Number
3005670412
Address
8055 Ne Jacobson St Ste 700, Hillsboro, Oregon 97124, United States
Country
United States
ID: de8312ec-e9dc-41d1-b721-818d2c3a75de