Company
United StatesCeraSys Incorporated, La Mirada, CA – FDA Inspections
Inspection records and compliance data for CeraSys Incorporated in La Mirada, California. 3 FDA inspections on record (1 OAI), last inspected January 17, 2012.
Company Profile
This profile covers CeraSys Incorporated based in La Mirada, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected October 29, 2008. Last inspected January 17, 2012.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Design control - no procedures2 inspections
- DMR - not or inadequately maintained2 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 17, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 770865 |
| May 3, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 661480 |
| October 29, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 545672 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
CeraSys Incorporated
FEI Number
3005243880
Address
14747 Artesia Blvd Ste 5G, La Mirada, California 90638, United States
Country
United States
ID: 52c62a4c-c3c6-4da1-b082-d2feec8d68d5