Company
United StatesATS Manufacturing LLC., Elkhart, IN – FDA Inspections
Inspection records and compliance data for ATS Manufacturing LLC. in Elkhart, Indiana. 2 FDA inspections on record, 1 Form 483, last inspected August 18, 2017.
Company Profile
This profile covers ATS Manufacturing LLC. based in Elkhart, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 25, 2012. Last inspected August 18, 2017.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- DHR - not or inadequately maintained1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 18, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1023270 |
| May 25, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 783646 |
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
ATS Manufacturing LLC.
FEI Number
1827347
Address
2026 Sterling Ave, Elkhart, Indiana 46516, United States
Country
United States
ID: 3059e205-3e33-471f-9356-809da731d656