# FDA 483 - PHC Corporation - December 18, 2017

Source: https://www.globalkeysolutions.net/records/483/phc-corporation/85bdaba4-bf88-4e8e-a88d-e890257954be

> FDA 483 for PHC Corporation on December 18, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PHC Corporation
- Inspection Date: 2017-12-18
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Panasonic Healthcare Co., Ltd. in Wakimachi, Japan, revealed significant deficiencies in the firm's quality system for blood glucose monitors. Observations included inadequate design controls, specifically concerning the device owner's review and approval of design verification protocols, risk analyses, and design transfer activities. Additionally, the inspection cited issues with process validation for meter production, noting insufficient sample sizes and a lack of robust repeatability testing.

## Related Officers

- [Sean T. Creighton](https://www.globalkeysolutions.net/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)

Company: https://www.globalkeysolutions.net/companies/phc-corporation/16e378ca-1d09-4558-bc41-1d816f9fb9d6

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd