# FDA 483 - EMIT Corporation - September 06, 2018

Source: https://www.globalkeysolutions.net/records/483/emit-corporation/9c56461a-7370-4952-b074-b4065453d562

> FDA 483 for EMIT Corporation on September 06, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EMIT Corporation
- Inspection Date: 2018-09-06
- Product Type: device
- Office Name: Dallas District Office
- Summary: BMIT Corporation, a medical device manufacturer in Houston, TX, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's design control procedures, specifically regarding design validation and the establishment of design plans. These issues indicate a lack of adequate documentation and timely execution of critical design and development activities for their medical devices.

## Related Documents

- [483 - 2023-03-07](https://www.globalkeysolutions.net/records/483/emit-corporation/10f491d7-a5e7-437d-bf39-087f8bf86b1e)

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/emit-corporation/bc663eef-9692-4ff5-a455-9cec45414556

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9