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483
•MECTA Corporation•September 1, 2009

MECTA Corporation – FDA 483, Sep 1, 2009

Record Details

Mecta Corporation in Tualatin, OR, was inspected by the FDA from August to September 2009. The inspection revealed a significant issue regarding medical device reporting. Specifically, the firm failed to submit a timely Medical Device Report (MDR) after becoming aware of a patient's death following treatment with their Spectrum 5000Q device.

Company
MECTA Corporation
Inspection date
September 1, 2009
Product type
device
Office
Division of Human and Animal Food Operations - West VI
Person
  • Lorna F Jones
View Company Profile

ID · d3557811-7265-4502-9987-7e45e5f87475

Other documents for MECTA Corporation
  • 483 - 2015-06-30June 30, 2015

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