FDA EIR - Evonik Operations GmbH - May 18, 2017

An FDA pre-approval inspection was conducted at Evonik Nutrition and Care GmbH in Darmstadt, Germany, from May 15-18, 2017. The inspection evaluated the facility as a manufacturer of pharmaceutical excipients for animal drugs, under the regulatory frameworks of cGMP regulations and 'The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients.' The company was seeking approval for an excipient under a New Animal Drug Application (NADA) and Veterinary Master File (VMF).

At the inspection's conclusion, an FDA-483, 'Inspectional Observations,' was issued. The primary observation highlighted that the responsibilities and procedures of the quality control unit were not fully followed. Specifically, deviation investigations were found to be closed prematurely, before corrective actions were completed and their effectiveness verified. Additionally, these investigation reports lacked comprehensive documentation of the corrective action plans, effectiveness checks, and supporting evidence. For example, one deviation investigation was closed before necessary equipment repairs were even performed.

To address these findings, Evonik Nutrition and Care GmbH is required to ensure that all deviation investigations are thoroughly completed, including the implementation and documentation of corrective actions and effectiveness checks, prior to their closure. Complete and detailed records of these processes must be maintained within the investigation reports. Company management promised to provide a written response to the FDA-483.