FDA WARNING_LETTER - GETSCH+HILLER MEDIZINTECHNIK GmbH - July 21, 2022

On December 27, 2022, the FDA issued a Warning Letter to Getsch + Hiller GmbH following an inspection from July 18-21, 2022, in Tuttlingen, Nendingen, Germany. The firm manufactures Monopolar Laparoscopic Instruments, which are considered adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain Design History Files (DHF)** for Class II Monopolar Laparoscopic Instruments with reusable tips intended for the US market (21 CFR 820.30(j)). The firm's response, which included blocking shipments and plans to revise procedures, was deemed inadequate for not addressing risk evaluation for devices already distributed in the US. 2. **Failure to establish and maintain procedures for incoming product acceptance** (21 CFR 820.80(b)). Raw materials were found in the CNC Department that had not undergone the incoming acceptance process but were labeled as approved. The firm's response, detailing plans for quarantine area markings and employee training, was inadequate for not including a plan to analyze existing records for potential impact on device specifications or nonconforming product release.

Additionally, the Monopolar Laparoscopic Instruments are adulterated because