FDA Inspection 678287 — Llorens Pharmaceuticals International Division, Inc.
The FDA completed an inspection of Llorens Pharmaceuticals International Division, Inc. on September 30, 2010 in Miami, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 30, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2089 | 21 CFR 211.208 | No records maintained |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |