FDA Inspection 570531 — Sterigenics US, LLC
The FDA completed an inspection of Sterigenics US, LLC on March 18, 2009 in Willowbrook, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 18, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Willowbrook, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1697 | 21 CFR 110.80(b)(4) | Preventive control measures |
| 3225 | 21 CFR 820.70(g)(3) | Adjustment |
| 3227 | 21 CFR 820.70(g)(1) | Activity documentation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |