FDA Inspection 553028 — Isomedix Operations, Inc.
The FDA completed an inspection of Isomedix Operations, Inc. on November 26, 2008 in Ontario, 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
- November 26, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |
| 3694 | 21 CFR 820.100(a)(6) | Dissemination of problem information |