Company
United StatesMyelotec, Inc., Roswell, GA – FDA Inspections
Inspection records and compliance data for Myelotec, Inc. in Roswell, Georgia. 2 FDA inspections on record, 1 Form 483, last inspected February 01, 2017.
Company Profile
This profile covers Myelotec, Inc. based in Roswell, Georgia, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected November 14, 2012. Last inspected February 1, 2017.
Most cited issue areas
- Design validation - production units1 inspection
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 1, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1008530 |
| November 14, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 809094 |
FDA documents
Form 483s (1)
EIRs (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Myelotec, Inc.
FEI Number
3000215691
Address
4000 Northfield Way Ste 900, Roswell, Georgia 30076, United States
Country
United States
ID: 7e8b04cf-e54d-41f9-9e96-6e256646cb36