FDA WARNING_LETTER - WEBER MEDICAL GMBH - January 17, 2013

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