FDA inspection
Ophtapharm AG: FDA inspection ending Jul 7, 2023
FDA inspection 1245095 · Voluntary Action Indicated (VAI) · Winterthur
Key facts
| Inspection ID | 1245095 |
|---|---|
| Firm | Ophtapharm AG |
| FEI number | 3005531475 |
| Address | Technoparkstrasse 7 |
| City | Winterthur |
| Fiscal year | 2023 |
| Inspection end date | Jul 7, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Drug Quality Assurance|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data