# FDA 483 - WatchChild, LLC - August 23, 2019

Source: https://www.globalkeysolutions.net/records/483/watchchild-llc/87e1d13c-0d3f-440a-8daa-2c0253e7e910

> FDA 483 for WatchChild, LLC on August 23, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WatchChild, LLC
- Inspection Date: 2019-08-23
- Product Type: device
- Office Name: Atlanta District Office
- Summary: WatchChild, LLC, a medical device manufacturer in Cary, NC, was inspected by the FDA. The inspection revealed multiple deficiencies in their quality system, primarily concerning inadequate documentation, lack of established procedures, and insufficient control over product acceptance and nonconformance. These issues indicate a need for significant improvements in their manufacturing and quality control processes.

## Related Officers

- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/watchchild-llc/d67cec22-78d7-4dd8-a66f-377f9bb81c54

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7