# FDA 483 - Spring Health Products Inc - March 22, 2022

Source: https://www.globalkeysolutions.net/records/483/spring-health-products-inc/8488fccb-cc98-4e04-b7b5-bbb043bec44a

> FDA 483 for Spring Health Products Inc on March 22, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spring Health Products Inc
- Inspection Date: 2022-03-22
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Spring Health Products Inc. in Norristown, PA, a medical device manufacturer, received a Form FDA 483 with two observations during an inspection. The firm was cited for failing to establish procedures for design changes related to their dental curing lights and for not maintaining a Device Master Record for these devices. These deficiencies indicate a lack of adherence to medical device quality system regulations.

## Related Documents

- [483 - 2018-12-18](https://www.globalkeysolutions.net/records/483/spring-health-products-inc/ee970705-8c8f-462c-8e10-3ace46284f93)

## Related Officers

- [Investigations](https://www.globalkeysolutions.net/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.globalkeysolutions.net/companies/spring-health-products-inc/55586c15-6c74-4bca-b59a-c114ce5957bf

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8