Company
United StatesSagemax Bioceramics, Inc., Federal Way, WA – FDA Inspections
Inspection records and compliance data for Sagemax Bioceramics, Inc. in Federal Way, Washington. 5 FDA inspections on record (1 OAI), 1 warning letter, last inspected October 13, 2017.
Company Profile
This profile covers Sagemax Bioceramics, Inc. based in Federal Way, Washington, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 1
First inspected July 2, 2010. Last inspected October 13, 2017.
Most cited issue areas
- Design control - no procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 13, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1030254 |
| June 3, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 930078 |
| August 18, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 892877 |
| January 24, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 766593 |
| July 2, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 672024 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sagemax Bioceramics, Inc.
FEI Number
3007518500
Address
34210 9th Ave S Ste 118, Federal Way, Washington 98003, United States
Country
United States
ID: d0722b2a-216f-4633-8083-7165ce27c6aa