# FDA WARNING_LETTER - WEBER MEDICAL GMBH - January 17, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/weber-medical-gmbh/a4fcb3b9-56f7-40d5-90b0-1eb69193b6df

> FDA WARNING_LETTER for WEBER MEDICAL GMBH on January 17, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: WEBER MEDICAL GMBH
- Inspection Date: 2013-01-17
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On January 14-17, 2013, an FDA inspection of Weber Medical GmbH in Lauenfoerde, Germany, revealed that their Weberneedle device is adulterated under 21 U.S.C. § 351(h) because its manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations include:
- **Failure to establish and maintain design validation procedures (21 CFR 820.30(g)):** The user manual lacks instructions for the patient switch, and the firm's response lacked documentation of corrections.
- **Failure to evaluate and select suppliers based on quality requirements (21 CFR 820.50(a)(1)):** Supplier (b)(4) lacks a quality management system and their contract doesn't include FDA QS regulation requirements. The firm's response lacked documentation of corrections.
- **Failure to define control over suppliers based on evaluation results (21 CFR 820.50(a)(2)):** The supplier grading system doesn't specify criteria for required corrective actions. The firm provided no written response to this observation.
- **Failure to maintain Device History Records (DHRs) (21 CFR 820.184):** No DHRs exist for components manufactured by

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## Related Officers

- [President](https://www.globalkeysolutions.net/people/steven-d-silverman/06ce6082-cb19-469c-bcba-c368d335b0df)

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

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7