Company
United StatesMIE America, Inc., Elk Grove Village, IL – FDA Inspections
Inspection records and compliance data for MIE America, Inc. in Elk Grove Village, Illinois. 2 FDA inspections on record, 2 Form 483s, last inspected September 14, 2023.
Company Profile
This profile covers MIE America, Inc. based in Elk Grove Village, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected January 8, 2018. Last inspected September 14, 2023.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Management ensuring quality policy is understood1 inspection
- Quality audits - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 14, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1217671 |
| January 8, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1037046 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
MIE America, Inc.
FEI Number
3000210013
Address
420 Bennett Rd, Elk Grove Village, Illinois 60007, United States
Country
United States
ID: a1a7c905-2644-442b-8b33-caddfb71a6ac