Company
United StatesAspire Bariatrics LLC, Exton, PA – FDA Inspections
Inspection records and compliance data for Aspire Bariatrics LLC in Exton, Pennsylvania. 3 FDA inspections on record, 1 Form 483, last inspected August 31, 2017.
Company Profile
This profile covers Aspire Bariatrics LLC based in Exton, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 18, 2015. Last inspected August 31, 2017.
Most cited issue areas
- Complaints1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 31, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1024937 |
| April 19, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 967018 |
| February 18, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 914940 |
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
Aspire Bariatrics LLC
FEI Number
3009595931
Address
319 North Pottstown Pike Ste 202, Exton, Pennsylvania 19341, United States
Country
United States
ID: 6d518763-4447-42d0-9c8d-ac92792232b6