Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-23.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 May 2025 – 23 May 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Nov 2023 – 1 Dec 2023 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 May 2025
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Gregory M Bessette, Fouad Attioui
23 May 2025
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Gregory M Bessette, Fouad Attioui
1 Dec 2023
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Francis Pham, Goushi Kubota
1 Dec 2023
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Francis Pham, Goushi Kubota
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1030.10(c)(3)(i) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind PRATICA KLIMAQUIP IND. E COM. S.A.'s 2 Form 483s
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat