# FDA 483 - Nusmile, Ltd. - April 16, 2018

Source: https://www.globalkeysolutions.net/records/483/nusmile-ltd/04f22891-a78f-4c07-95ce-36b8d81b08a9

> FDA 483 for Nusmile, Ltd. on April 16, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nusmile, Ltd.
- Inspection Date: 2018-04-16
- Product Type: device
- Office Name: Dallas District Office
- Summary: Nusmile, Ltd., a medical device manufacturer in Houston, TX, was inspected by the FDA and received a Form 483 with nine observations. The inspection revealed significant deficiencies across multiple quality system areas, including process validation, nonconforming product control, acceptance activities, CAPA documentation, equipment maintenance, complaint handling, and process control procedures. These issues indicate a systemic lack of adherence to established quality requirements for their MTA Gel products.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/nusmile-ltd/6ed120ed-63cf-4593-823a-b47f430e683c

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