# FDA 483 - WEBER MEDICAL GMBH - November 08, 2018

Source: https://www.globalkeysolutions.net/records/483/weber-medical-gmbh/e1ff6001-2701-45f7-8898-fcf47989e56f

> FDA 483 for WEBER MEDICAL GMBH on November 08, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: WEBER MEDICAL GMBH
- Inspection Date: 2018-11-08
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: WEBER MEDICAL GMBH in Lauenfoerde, Germany, was inspected by the FDA from November 5-8, 2018, and received 15 observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning complaint handling, design control, non-conformance control, CAPA, supplier management, and medical device reporting. Additionally, numerous issues were identified with the labeling and safety features of their Class IIIb and Class IV laser products, indicating a broad lack of compliance with regulatory standards.

## Related Documents

- [WARNING_LETTER - 2013-01-17](https://www.globalkeysolutions.net/records/warning_letter/weber-medical-gmbh/a4fcb3b9-56f7-40d5-90b0-1eb69193b6df)
- [483 - 2018-11-05](https://www.globalkeysolutions.net/records/483/weber-medical-gmbh/cef1b36f-e3ec-4f3b-aa47-94d9ed0e7089)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.globalkeysolutions.net/companies/weber-medical-gmbh/750376b8-e96f-41fc-a95f-21bfa440787e

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