FDA Inspection 951256 — Biogen U.S. Corporation
The FDA completed an inspection of Biogen U.S. Corporation on Dec 10, 2015 in Morrisville, NC. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morrisville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |