# FDA 483 - MECTA Corporation - September 01, 2009

Source: https://www.globalkeysolutions.net/records/483/mecta-corporation/d3557811-7265-4502-9987-7e45e5f87475

> FDA 483 for MECTA Corporation on September 01, 2009. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MECTA Corporation
- Inspection Date: 2009-09-01
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Documents

- [483 - 2015-06-30](https://www.globalkeysolutions.net/records/483/mecta-corporation/33afc86a-93e6-4d48-a5f7-19b900706b7a)

## Related Officers

- [Lorna F Jones](https://www.globalkeysolutions.net/people/lorna-f-jones/cca586b5-fbf4-4acc-9e36-cdb76ef7de23)

Company: https://www.globalkeysolutions.net/companies/mecta-corporation/58c14e8a-cc3c-4103-9b53-8bc6dea3cae5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822