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Fogless International AB, Vaggeryd, Sweden – FDA Inspections

Inspection records and compliance data for Fogless International AB in Vaggeryd. 1 FDA inspection on record, 1 Form 483, last inspected August 28, 2025.

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Company Profile

This profile covers Fogless International AB based in Vaggeryd, Sweden.

FDA Inspection History

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

Inspected August 28, 2025.

Most cited issue areas

  • Design history file1 inspection
  • Lack of Written MDR Procedures1 inspection
  • Quality audits - Lack of or inadequate procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
August 28, 2025Not classifiedMedical Devices & Rad Health · Compliance: Medical Devices1280400
FDA documents

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

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Company Information

Name

Fogless International AB

FEI Number

3014054118

Address

Storgatan 24, Vaggeryd, Sweden

Country

Sweden

ID: c68b062a-421c-430c-b984-6f4aad25a655

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