Company
United StatesAtritech, Inc, Plymouth, MN – FDA Inspections
Inspection records and compliance data for Atritech, Inc in Plymouth, Minnesota. 2 FDA inspections on record, last inspected February 04, 2009.
Company Profile
This profile covers Atritech, Inc based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 27, 2009. Last inspected February 4, 2009.
Most cited issue areas
- Investigator non-compliance with agreement/plan/regulations1 inspection
- Sponsor notification of IRB approval withdrawal1 inspection
- Sponsors" general responsibilities1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 4, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 559861 |
| January 27, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 558589 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Atritech, Inc
FEI Number
3007338617
Address
3750 Annapolis Ln N Suite #105, Plymouth, Minnesota 55447, United States
Country
United States
ID: a0ae5bf3-ec37-41f6-a4e8-72531203dfb5