FDA Inspection 644445 — Isomedix Operations Inc
The FDA completed an inspection of Isomedix Operations Inc on Jan 27, 2010 in Groveport, OH. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 27, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Groveport, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3694 | 21 CFR 820.100(a)(6) | Dissemination of problem information |
| 3696 | 21 CFR 820.100(b) | Documentation |