FDA Inspection 738229 — Llorens Pharmaceuticals International Division, Inc.
The FDA completed an inspection of Llorens Pharmaceuticals International Division, Inc. on Aug 1, 2011 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 1, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |