Company
NetherlandsGelita Medical B.v., Amsterdam, Netherlands – FDA Inspections
Inspection records and compliance data for Gelita Medical B.v. in Amsterdam. 1 FDA inspection on record, last inspected April 15, 2010.
Company Profile
This profile covers Gelita Medical B.v. based in Amsterdam, Netherlands.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected April 15, 2010.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 15, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 661042 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gelita Medical B.v.
FEI Number
3005759666
Address
Osdorperweg 590, Amsterdam, Netherlands
Country
Netherlands
ID: 6b1bf1fc-1a43-45dc-b5d0-207bc40c6712