FDA Inspection
PRACTICE KLIMAQUIP IND. E COM. S.A.PRACTICE KLIMAQUIP IND. E COM. S.A. – FDA Inspection, May 23, 2025
Record Details
This FDA Inspection record concerns PRACTICE KLIMAQUIP IND. E COM. S.A., with an inspection on May 23, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 23, 2025
- Product Type
- Medical Devices & Rad Health
- People
- Fouad Attioui (Issuing Officer)
- Gregory M. Bessette (Issuing Officer)
View Company Profile
ID · d5d2833b-8801-4429-add0-f17d1011ad1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1270568
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act (RCHSA) Authority
- Outcome
- Form 483 issued
FDA Citations
2- 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
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PRACTICE KLIMAQUIP IND. E COM. S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2023 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for PRACTICE KLIMAQUIP IND. E COM. S.A.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.