# FDA 483 - Plexus Electronica S. de R.L. de C.V. - November 29, 2018

Source: https://www.keypedia.com/records/483/plexus-electronica-s-de-rl-de-cv/4cc2b294-8342-4efe-ac4d-4fbcdfb7eca4

> FDA 483 for Plexus Electronica S. de R.L. de C.V. on November 29, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Plexus Electronica S. de R.L. de C.V.
- Inspection Date: 2018-11-29
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2018-11-26](https://www.keypedia.com/records/483/plexus-electronica-s-de-rl-de-cv/46770d4a-7420-4980-b8a8-6ee389e8867e)

## Related Officers

- [Business Owner](https://www.keypedia.com/people/james-whitney/072bf37e-a5c6-41bb-b0c1-1f944b112b43)

Company: https://www.keypedia.com/companies/plexus-electronica-s-de-rl-de-cv/b64c5d23-9567-4d11-95da-ba86f3786482

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd