Company
Czech RepublicICU Medical Czech Republic a. s., Hranice, Czech Republic – FDA Inspections
Inspection records and compliance data for ICU Medical Czech Republic a. s. in Hranice. 1 FDA inspection on record, 1 Form 483, last inspected September 18, 2025.
Company Profile
This profile covers ICU Medical Czech Republic a. s. based in Hranice, Czech Republic.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected September 18, 2025.
Most cited issue areas
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1282590 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ICU Medical Czech Republic a. s.
FEI Number
3011237704
Address
Olomoucka 306, Hranice, Czech Republic
Country
Czech Republic
ID: 34e19865-dee3-46d5-a211-851044b9acdc