# FDA 483 - EMED Technologies Corporation - March 17, 2021

Source: https://www.globalkeysolutions.net/records/483/emed-technologies-corporation/94b9e3f6-b9f5-4e70-a6e7-11d055d9463a

> FDA 483 for EMED Technologies Corporation on March 17, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EMED Technologies Corporation
- Inspection Date: 2021-03-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: During an FDA inspection from March 11-17, 2021, EMED Technologies Corporation, a medical device manufacturer in El Dorado Hills, CA, was cited for inadequate complaint handling procedures. The firm's procedures failed to properly define requirements for evaluating complaints to determine if they were reportable to the FDA, a critical lapse demonstrated by numerous unassessed complaint records involving device malfunctions. This indicates a significant deficiency in their quality system regarding post-market surveillance and regulatory reporting.

## Related Officers

- [Linda Linh N Adams](https://www.globalkeysolutions.net/people/linda-linh-n-adams/7bc1bb60-951a-4d10-84b4-c105fc857171)

Company: https://www.globalkeysolutions.net/companies/emed-technologies-corporation/43666fe5-6789-46cc-ae50-729f2351866a

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b