Company
United StatesHeraeus Medical Components LLC, Plymouth, MN – FDA Inspections
Inspection records and compliance data for Heraeus Medical Components LLC in Plymouth, Minnesota. 3 FDA inspections on record, last inspected October 05, 2016.
Company Profile
This profile covers Heraeus Medical Components LLC based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected August 25, 2010. Last inspected October 5, 2016.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 5, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1016481 |
| July 2, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 839975 |
| August 25, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 680181 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
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Company Information
Name
Heraeus Medical Components LLC
FEI Number
3003631559
Address
2605 Fernbrook Ln N Ste J, Plymouth, Minnesota 55447, United States
Country
United States
ID: 2f257307-9b56-4404-bca5-a643a3219c40