FDA Inspection 1178163 — Sterigenics US, LLC
The FDA completed an inspection of Sterigenics US, LLC on August 23, 2022 in Fort Worth, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |