Company
United StatesABL Medical, LLC, American Fork, UT – FDA Inspections
Inspection records and compliance data for ABL Medical, LLC in American Fork, Utah. 5 FDA inspections on record, last inspected January 10, 2023.
Company Profile
This profile covers ABL Medical, LLC based in American Fork, Utah, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected June 30, 2010. Last inspected January 10, 2023.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 10, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1194783 |
| May 30, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1053989 |
| May 21, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 928095 |
| August 30, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 797283 |
| June 30, 2010 | VAI | Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 671260 |
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
ABL Medical, LLC
FEI Number
3007536356
Address
701 E 50 S, American Fork, Utah 84003, United States
Country
United States
ID: cfe76b8c-0daa-47b5-b28b-5877a52400aa