Company
United StatesOrmco/Sybronendo, Glendora, CA – FDA Inspections
Inspection records and compliance data for Ormco/Sybronendo in Glendora, California. 4 FDA inspections on record, 1 Form 483, last inspected July 21, 2017.
Company Profile
This profile covers Ormco/Sybronendo based in Glendora, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 20, 2010. Last inspected July 21, 2017.
Most cited issue areas
- Lack of or inadequate In-process acceptance procedures1 inspection
- Report of Death or Serious Injury1 inspection
- Retention period1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 21, 2017 | Not classified | Medical Devices & Rad Health | 1031062 |
| January 24, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 763710 |
| June 29, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 731636 |
| January 20, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 641489 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ormco/Sybronendo
FEI Number
2016150
Address
1332 S Lone Hill Ave, Glendora, California 91740, United States
Country
United States
ID: 0426de4f-aa4d-4880-8752-521e95ec8eeb