FDA inspection

Villa Sistemi Medicali S.P.A.: FDA inspection ending Jul 24, 2015

FDA inspection 939614 · No Action Indicated (NAI) · Buccinasco

Key facts

Inspection ID	939614
Firm	Villa Sistemi Medicali S.P.A.
FEI number	3002808461
Address	Via delle Azalee 3
City	Buccinasco
Fiscal year	2015
Inspection end date	Jul 24, 2015
Classification	No Action Indicated (NAI)
Project area	Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority
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
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

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