Company
United StatesMcNeil Healthcare, LLC, Fairfield, NJ – FDA Inspections
Inspection records and compliance data for McNeil Healthcare, LLC in Fairfield, New Jersey. 4 FDA inspections on record, last inspected October 28, 2025.
Company Profile
This profile covers McNeil Healthcare, LLC based in Fairfield, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 24, 2014. Last inspected October 28, 2025.
Most cited issue areas
- Lack of or inadequate DHR procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Management representative1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1290488 |
| October 24, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1107838 |
| August 13, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 939045 |
| June 24, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 885904 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
McNeil Healthcare, LLC
FEI Number
1000305719
Address
311 Route 46 W Ste C, Fairfield, New Jersey 07004, United States
Country
United States
ID: 0e851103-e3f5-4c43-9e7e-4fd4caee4c50