FDA Inspection 1177943 — Isomedix Operations Inc
The FDA completed an inspection of Isomedix Operations Inc on July 25, 2022 in Groveport, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 25, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Groveport, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |