FDA Inspection 1215298 — Sterigenics U.S., LLC
The FDA completed an inspection of Sterigenics U.S., LLC on August 15, 2023 in Rockaway, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 15, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: 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 |