FDA Inspection 1032396 — Isomedix Operations Inc
The FDA completed an inspection of Isomedix Operations Inc on Nov 30, 2017 in Groveport, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 30, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Groveport, OH (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 |