FDA Inspection 1227211 — Marini Y Compania, S.A.
The FDA completed an inspection of Marini Y Compania, S.A. on Jan 18, 2024 in Carlos Spegazzini. 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
- Jan 18, 2024
- Fiscal Year
- 2024
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Carlos Spegazzini (Argentina)
Citations
| ID | CFR | Description |
|---|---|---|
| 21300 | 21 CFR 507.33(a) | Hazard Analysis |
| 21304 | 21 CFR 507.34(c)(2) | Sanitation Controls |
| 21310 | 21 CFR 507.42(a)(1) | Establishment and Implementation of Corrective Action Procedures |
| 21323 | 21 CFR 507.49(b)(2) | Written Product Testing Procedures |
| 21324 | 21 CFR 507.49(b)(3) | Written Environmental Monitoring Procedures |