FDA Inspection 991891 — Beutlich Pharmaceuticals LLC
The FDA completed an inspection of Beutlich Pharmaceuticals LLC on November 4, 2016 in Bunnell, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bunnell, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |