FDA Inspection 1208719 — Sartorius Stedim North America, Inc.
The FDA completed an inspection of Sartorius Stedim North America, Inc. on June 23, 2023 in Cambridge, MA. 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
- June 23, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cambridge, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |