FDA Inspection 1050315 — Sterigenics U.S. LLC
The FDA completed an inspection of Sterigenics U.S. LLC on Apr 27, 2018 in Mulberry, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 27, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mulberry, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |