FDA Inspection 773041 — Beutlich Pharmaceuticals LLC
The FDA completed an inspection of Beutlich Pharmaceuticals LLC on Mar 30, 2012 in Bunnell, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 30, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- 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 |