FDA inspection

Sedecal S.A.: FDA inspection ending Feb 11, 2016

FDA inspection 959528 · Algete

Key facts

Inspection ID	959528
Firm	Sedecal S.A.
FEI number	3002495042
Address	Pol. Industrial Rio De Janiero, Calle Pelaya 9-13
City	Algete
Fiscal year	2016
Inspection end date	Feb 11, 2016
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 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: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority\|Compliance: Medical Devices\|Rad Cntrl & Hlth Safety Act (RCHSA) Auth\|Radiation Control and Health Safety Act (RCHSA) Authority
Product type	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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