FDA Inspection 1102946 — Lusomedicamenta Sociedade Tecnica Farmaceutica S.A
The FDA completed an inspection of Lusomedicamenta Sociedade Tecnica Farmaceutica S.A on September 27, 2019 in Barcarena. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Barcarena (Portugal)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |