Company
Czech RepublicGCE S.R.O., Chotebor, Czech Republic – FDA Inspections
Inspection records and compliance data for GCE S.R.O. in Chotebor. 1 FDA inspection on record, last inspected March 14, 2024.
Company Profile
This profile covers GCE S.R.O. based in Chotebor, Czech Republic.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected March 14, 2024.
Most cited issue areas
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 14, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1233579 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GCE S.R.O.
FEI Number
3003207908
Address
Zizkova 381, Chotebor, Czech Republic
Country
Czech Republic
ID: 1a797d8c-f484-43cb-9198-e2429a056a1b