# FDA 483 - EMIT Corporation - March 07, 2023

Source: https://www.globalkeysolutions.net/records/483/emit-corporation/10f491d7-a5e7-437d-bf39-087f8bf86b1e

> FDA 483 for EMIT Corporation on March 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EMIT Corporation
- Inspection Date: 2023-03-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of EMIT Corporation, a medical device manufacturer in Houston, TX, revealed significant deficiencies in its complaint investigation records. The firm failed to document required information for device clinical incidents, including details of complaints, reportability assessments, and product history reviews. Additionally, the company's complaint handling procedures lacked provisions for capturing and documenting Unique Device Identification (UDI) information.

## Related Documents

- [483 - 2018-09-06](https://www.globalkeysolutions.net/records/483/emit-corporation/9c56461a-7370-4952-b074-b4065453d562)

## 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/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab