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483
•Plexus Electronica S. de R.L. de C.V.•November 29, 2018

Plexus Electronica S. de R.L. de C.V. – FDA 483, Nov 29, 2018

Record Details

Plexus Electronica S. de R.L. de C.V. in Zapopan, Jalisco, Mexico, was inspected by the FDA from November 26-29, 2018. The inspection revealed that the firm's procedures for receiving, reviewing, and evaluating complaints were not adequately established. Specifically, the firm failed to close medical device complaints in a timely manner, with several complaints remaining open for an average of 121 days.

Company
Plexus Electronica S. de R.L. de C.V.
Inspection date
November 29, 2018
Product type
device
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person
  • James Whitney (Business Owner)
View Company Profile

ID · 4cc2b294-8342-4efe-ac4d-4fbcdfb7eca4

Other documents for Plexus Electronica S. de R.L. de C.V.
  • 483 - 2018-11-26November 26, 2018

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