FDA Inspection 1201601 — Fresenius Kabi Compounding, LLC
The FDA completed an inspection of Fresenius Kabi Compounding, LLC on Mar 6, 2023 in Canton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 6, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Canton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |