# FDA 483 - Apical Instruments Inc - February 13, 2020

Source: https://www.globalkeysolutions.net/records/483/apical-instruments-inc/a5a92fe6-7f05-44a9-b276-d9e3b77bd9f1

> FDA 483 for Apical Instruments Inc on February 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apical Instruments Inc
- Inspection Date: 2020-02-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Pascal Instruments Inc in Redwood City, CA, was inspected by the FDA from February 10-13, 2020. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of non-conforming products, insufficient equipment verification, poor documentation of acceptance activities, and a lack of proper employee training. These issues indicate a moderate level of non-compliance with medical device quality system regulations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.globalkeysolutions.net/companies/apical-instruments-inc/b9e66159-8571-481d-9091-d218621c967a

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