Company
United StatesBig River Engineering and Manufacturing, Memphis, TN – FDA Inspections
Inspection records and compliance data for Big River Engineering and Manufacturing in Memphis, Tennessee. 3 FDA inspections on record, last inspected February 16, 2022.
Company Profile
This profile covers Big River Engineering and Manufacturing based in Memphis, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected January 15, 2015. Last inspected February 16, 2022.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Production processes1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 16, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1164251 |
| June 14, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 978243 |
| January 15, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 911619 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Big River Engineering and Manufacturing
FEI Number
3010041410
Address
85 N 4th St, Memphis, Tennessee 38103, United States
Country
United States
ID: ba9de343-d59b-400e-b5f5-8aa67fe8e74c