Company
United StatesCylex, Inc., Columbia, MD – FDA Inspections
Inspection records and compliance data for Cylex, Inc. in Columbia, Maryland. 2 FDA inspections on record, last inspected June 11, 2012.
Company Profile
This profile covers Cylex, Inc. based in Columbia, Maryland, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 17, 2008. Last inspected June 11, 2012.
Most cited issue areas
- Design input approval documentation1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification acceptance criteria1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 11, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 785785 |
| December 17, 2008 | VAI | Medical Devices & Rad Health · Compliance: Devices | 552589 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cylex, Inc.
FEI Number
3003920771
Address
8980 State Route 108 Ste I, Columbia, Maryland 21045, United States
Country
United States
ID: 8f0272cf-a5ee-45c0-80d7-4a41e455982e