FDA inspection
AMO Manufacturing USA, LLC: FDA inspection ending Mar 3, 2008
FDA inspection 509048 · Official Action Indicated (OAI) · Milpitas, CA
Key facts
| Inspection ID | 509048 |
|---|---|
| Firm | AMO Manufacturing USA, LLC |
| FEI number | 3006695864 |
| Address | 510 Cottonwood Dr |
| City | Milpitas |
| State | CA |
| ZIP | 95035-7403 |
| Fiscal year | 2008 |
| Inspection end date | Mar 3, 2008 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Med 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Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Product Evaluation: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No 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