FDA Inspection 1059418 — Haupt Pharma Latina Srl
The FDA completed an inspection of Haupt Pharma Latina Srl on Jun 28, 2018 in Latina. 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 28, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Latina (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |