Company
United StatesApplied Medical Technology Inc, Brecksville, OH – FDA Inspections
Inspection records and compliance data for Applied Medical Technology Inc in Brecksville, Ohio. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected February 09, 2018.
Company Profile
This profile covers Applied Medical Technology Inc based in Brecksville, Ohio, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 29, 2011. Last inspected February 9, 2018.
Most cited issue areas
- Lack of System for Determining MDR Events1 inspection
- Production processes1 inspection
- Product rework procedures, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 9, 2018 | Not classified | Medical Devices & Rad Health | 1051777 |
| April 3, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 773307 |
| April 29, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 722295 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Applied Medical Technology Inc
FEI Number
1526012
Address
8006 Katherine Blvd, Brecksville, Ohio 44141, United States
Country
United States
ID: 4ea29951-1dc7-4a96-8fc9-e0c55ae6b6e5