FDA Inspection
CLUNAS SP. Z O.O. ULCLUNAS SP. Z O.O. UL – FDA Inspection, May 23, 2024
Record Details
This FDA Inspection record concerns CLUNAS SP. Z O.O. UL, with an inspection on May 23, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d158dd40-1a77-42bc-9eca-11de17e597e8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1239272
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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