FDA 483 - Siegfried Evionnaz SA - March 31, 2023

An FDA inspection conducted at Siegfried Evionnaz SA, an API manufacturer in Evionnaz, Switzerland, from March 27-31, 2023, resulted in a Form FDA 483 detailing three significant observations. These observations highlight deviations from expected manufacturing and quality standards for active pharmaceutical ingredients.

Firstly, production equipment, specifically a dryer used for manufacturing intermediates and APIs, was found to be unsuitable for its intended purpose. Significant physical damage, including scratches and dents, was observed on its surface. This damage, caused by using hard tools to break hardened product, raises concerns about proper cleaning and potential cross-contamination risks for multiple products, including those destined for the US market.

Secondly, the firm's quality unit failed to adhere to its own procedures for monitoring API stability. Numerous stability samples, including annual batches of a key API, were not tested within the prescribed timelines, with delays extending to a year or more. This indicates a lapse in ensuring the continued quality and shelf-life of products.

Finally, the inspection revealed that a warehouse used for storing raw materials and intermediates was not adequately maintained. Rainwater was observed leaking from the roof, accumulating near drums of an intermediate used in US-market APIs. This issue was not new; a deviation regarding water-damaged materials from October 2021, and its corresponding corrective action plan, remained open and unresolved at the time of inspection, indicating a persistent facility maintenance deficiency.

Siegfried Evionnaz SA is required to respond to these observations with a plan for corrective and preventive actions to address the identified issues and ensure compliance with regulatory expectations for API manufacturing.