FDA Inspection 678287 — Llorens Pharmaceuticals International Division, Inc.
The FDA completed an inspection of Llorens Pharmaceuticals International Division, Inc. on Sep 30, 2010 in Miami, 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- 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 |