FDA Inspection
PRACTICE KLIMAQUIP IND. E COM. S.A.PRACTICE KLIMAQUIP IND. E COM. S.A. – FDA Inspection, Dec 1, 2023
Record Details
This FDA Inspection record concerns PRACTICE KLIMAQUIP IND. E COM. S.A., with an inspection on December 1, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 12f46c27-c89a-4efb-899b-e667c001ef7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223933
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
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Other FDA inspections of PRACTICE KLIMAQUIP IND. E COM. S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2025 | VAI | Office of Inspections and Investigations | Radiation Control and Health Safety Act (RCHSA) Authority |
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