FDA inspection
Lexington International, LLC: FDA inspection ending Nov 9, 2007
FDA inspection 495865 · Official Action Indicated (OAI) · Boca Raton, FL
Key facts
| Inspection ID | 495865 |
|---|---|
| Firm | Lexington International, LLC |
| FEI number | 3006182775 |
| Address | 1040 Holland Dr |
| City | Boca Raton |
| State | FL |
| ZIP | 33487-2759 |
| Fiscal year | 2008 |
| Inspection end date | Nov 9, 2007 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med 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Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Postmarket Assurance: Med Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth |
| Product type | Devices |
| Warning letter | UCM1048284 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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