# FDA 483 - Micro Current Technology, Inc. - January 28, 2019

Source: https://www.globalkeysolutions.net/records/483/micro-current-technology-inc/faed9d8d-f070-43fc-9398-35901cab13da

> FDA 483 for Micro Current Technology, Inc. on January 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Current Technology, Inc.
- Inspection Date: 2019-01-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Micro Current Technology, Inc., a manufacturer of Class 2 medical devices (TENS), identified significant deficiencies. The firm was cited for not having sampling plans based on valid statistical rationale, which was a recurring observation. Additionally, procedures for design changes were not adequately established, and validation of device software was incomplete.

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/micro-current-technology-inc/328c4758-ec34-481f-8513-9209948ffb80

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