# FDA 483 - Medical Measurement Systems B.V. - June 16, 2022

Source: https://www.globalkeysolutions.net/records/483/medical-measurement-systems-bv/61336781-f78e-4d7e-838d-1a236a1d6c87

> FDA 483 for Medical Measurement Systems B.V. on June 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Measurement Systems B.V.
- Inspection Date: 2022-06-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Medical Measurement Systems B.V., a medical device manufacturer in Enschede, Netherlands, identified five observations. The firm was cited for inadequate procedures across multiple quality system elements, including corrective and preventive actions, complaint handling, rework of nonconforming product, control of nonconforming product, and design input. These findings indicate significant deficiencies in the firm's quality management system.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/medical-measurement-systems-bv/d26f3f3c-0de4-4cd0-9429-c88f99055e57

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