Company
United StatesASI Medical, Inc., Englewood, CO – FDA Inspections
Inspection records and compliance data for ASI Medical, Inc. in Englewood, Colorado. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected February 02, 2018.
Company Profile
This profile covers ASI Medical, Inc. based in Englewood, Colorado, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected November 29, 2010. Last inspected February 2, 2018.
Most cited issue areas
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design history file1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2018 | Not classified | Medical Devices & Rad Health | 1081697 |
| December 17, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 907171 |
| December 22, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 760079 |
| November 29, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 699980 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ASI Medical, Inc.
FEI Number
1000160293
Address
8811 American Way Ste 130, Englewood, Colorado 80112, United States
Country
United States
ID: 2a8d7705-f786-427f-b830-b8201cd59ad3