FDA Inspection 1120499 — Llorens Pharmaceuticals International Division, Inc.
The FDA completed an inspection of Llorens Pharmaceuticals International Division, Inc. on Mar 11, 2020 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 11, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |