FDA Inspection 752163 — Birchwood Laboratories, LLC
The FDA completed an inspection of Birchwood Laboratories, LLC on November 4, 2011 in Eden Prairie, MN. 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
- November 4, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eden Prairie, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |