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•Czech Republic

STERIS AST CZ s.r.o., Velka Bites, Czech Republic – FDA Inspections

Inspection records and compliance data for STERIS AST CZ s.r.o. in Velka Bites. 1 FDA inspection on record, 1 Form 483, last inspected April 29, 2026.

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Company Profile

This profile covers STERIS AST CZ s.r.o. based in Velka Bites, Czech Republic.

FDA Inspection History

FDA inspections
1
OAI
0
VAI
0
NAI
0
Unclassified
1
Form 483s
1
Warning letters
0

Inspected April 29, 2026.

Most cited issue areas

  • Corrective action procedures not documented1 inspection
  • Product realization risk management processes not documented1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
April 29, 2026Not classifiedMedical Devices & Rad Health · Compliance: Devices1314542
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Company Information

Name

STERIS AST CZ s.r.o.

FEI Number

3004784537

Address

Prumyslova 698/80, Zona Kosikov, Velka Bites, Czech Republic

Country

Czech Republic

ID: 774fdf81-b730-4bcb-a737-208553bd7542

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