FDA Inspection 1070676 — Isomedix Operations, Inc.
The FDA completed an inspection of Isomedix Operations, Inc. on October 29, 2018 in Whippany, NJ. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Whippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |