# FDA 483 - MECTA Corporation - June 30, 2015

Source: https://www.globalkeysolutions.net/records/483/mecta-corporation/33afc86a-93e6-4d48-a5f7-19b900706b7a

> FDA 483 for MECTA Corporation on June 30, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MECTA Corporation
- Inspection Date: 2015-06-30
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of MECTA Corporation in Tualatin, OR, a medical device manufacturer, revealed three significant observations. The firm's procedures for design input were found to be inadequate due to conflicting software requirements, and design verification failed to confirm that design output met input requirements for their spECTrum Electro-Convulsive Therapy (ECT) devices. Additionally, procedures for routine equipment calibration were not adequately established, leading to undetected out-of-tolerance results for a final test fixture.

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- [483 - 2009-09-01](https://www.globalkeysolutions.net/records/483/mecta-corporation/d3557811-7265-4502-9987-7e45e5f87475)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

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