FDA Inspection 1120499 — Llorens Pharmaceuticals International Division, Inc.
The FDA completed an inspection of Llorens Pharmaceuticals International Division, Inc. on March 11, 2020 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 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 |