FDA inspection

SANMINA SCI Systems Malaysia Sdn. Bhd.: FDA inspection ending Oct 20, 2016

FDA inspection 992712 · Voluntary Action Indicated (VAI) · Perai

Key facts

Inspection ID	992712
Firm	SANMINA SCI Systems Malaysia Sdn. Bhd.
FEI number	3007923088
Address	202 Lorong Perusahaan Maju, 9
City	Perai
Fiscal year	2017
Inspection end date	Oct 20, 2016
Classification	Voluntary Action Indicated (VAI)
Project area	Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood & Blood Products\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Blood and Blood Products\|Compliance: Devices\|Compliance: Med Devices\|Compliance: Medical 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	Biologics, Devices

At a glance

1–9 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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