FDA 483 - RPC Formatec GmbH - May 27, 2022

RPC Formatec GmbH, a manufacturer of device constituent parts for combination products in Mellrichstadt, Germany, was cited for four observations during an FDA inspection. The observations primarily concern inadequate control of non-conforming products, deficiencies in the Design History File for the LupinHaler, ineffective quality audit procedures, and insufficient control over environmental conditions in the cleanroom. These issues indicate significant gaps in the firm's quality system.