FDA Inspection 1270563 — Sairem Corp.
The FDA completed an inspection of Sairem Corp. on May 16, 2025 in Decines-Charpieu. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 16, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Decines-Charpieu (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5117 | 21 CFR 1030.10(c)(2)(vi) | Means to monitor interlocks |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |