FDA inspection
Akorn Operating Company LLC: FDA inspection ending Aug 30, 2018
FDA inspection 1064286 · Official Action Indicated (OAI) · Somerset, NJ
Key facts
| Inspection ID | 1064286 |
|---|---|
| Firm | Akorn Operating Company LLC |
| FEI number | 2246848 |
| Address | 72 Veronica Ave |
| City | Somerset |
| State | NJ |
| ZIP | 08873-3426 |
| Fiscal year | 2018 |
| Inspection end date | Aug 30, 2018 |
| Classification | Official Action Indicated (OAI) |
| 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|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices|Monit of Marketed Animal Drug,Feed &Dev|Monitoring of Marketed Animal Drugs, Feed, and Devices|Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| Product type | Drugs |
| Warning letter | 568173 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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