FDA Inspection 773041 — Beutlich Pharmaceuticals LLC
The FDA completed an inspection of Beutlich Pharmaceuticals LLC on March 30, 2012 in Bunnell, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bunnell, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1371 | 21 CFR 211.101(a) | Batches Formulated to less than 100% |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |