FDA Inspection 1180892 — Steri-Pharma, LLC
The FDA completed an inspection of Steri-Pharma, LLC on October 4, 2022 in Syracuse, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 4, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Syracuse, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |