FDA Inspection 991592 — Willow Birch Pharma, LLC
The FDA completed an inspection of Willow Birch Pharma, LLC on Oct 28, 2016 in Taylor, MS. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 28, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Taylor, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |