FDA Inspection 716447 — Beutlich Pharmaceuticals LLC
The FDA completed an inspection of Beutlich Pharmaceuticals LLC on Feb 22, 2011 in Bunnell, FL. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bunnell, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 8938 | FDCA 760(c)(1) | Timing of AE report submission (non-RX drugs) |