FDA Inspection 1215298 — Sterigenics U.S., LLC
The FDA completed an inspection of Sterigenics U.S., LLC on Aug 15, 2023 in Rockaway, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 15, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rockaway, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3237 | 21 CFR 820.72(b) | Remedial action |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |