FDA Inspection
Fogless International ABFogless International AB – FDA Inspection, Aug 28, 2025
Record Details
This FDA Inspection record concerns Fogless International AB, with an inspection on August 28, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Fogless International AB
- Inspection Date
- August 28, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · fc2ae821-f825-4939-b3c6-6b4509b5d6c6
Inspection Facts
- Inspection number
- 1280400
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
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