# FDA 483 - Pfm Medical Cpp SA - July 11, 2018

Source: https://www.globalkeysolutions.net/records/483/pfm-medical-cpp-sa/a7b8f34b-8c1b-4788-a2e2-e2963dce810c

> FDA 483 for Pfm Medical Cpp SA on July 11, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pfm Medical Cpp SA
- Inspection Date: 2018-07-11
- Product Type: device
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Pfm Medical Cpp SA, a medical device manufacturer in La Chaux-de-Fonds, Switzerland, was cited for significant deficiencies in its Medical Device Reporting (MDR) system. The firm failed to submit MDR reports for several serious adverse events involving device malfunctions and patient injuries. Additionally, its written MDR procedure was found to be inadequate, lacking a comprehensive system for identifying, evaluating, and reporting such events.

## Related Documents

- [483 - 2018-07-09](https://www.globalkeysolutions.net/records/483/pfm-medical-cpp-sa/dc75c718-2f39-4977-a028-4959ed5463fb)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)

Company: https://www.globalkeysolutions.net/companies/pfm-medical-cpp-sa/d6cf40d4-24d4-4864-8d76-92537cf2eb91

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552