FDA Inspection 784882 — Sterigenics US, LLC
The FDA completed an inspection of Sterigenics US, LLC on June 7, 2012 in Hayward, CA. 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
- June 7, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hayward, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2032 | 21 CFR 211.194(b) | Test method modification records not maintained |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |