FDA Inspection 1270568 — PRATICA KLIMAQUIP IND. E COM. S.A.
The FDA completed an inspection of PRATICA KLIMAQUIP IND. E COM. S.A. on May 23, 2025 in Pouso Alegre. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Pouso Alegre (Brazil)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |