FDA 483 - Micro-Macinazione SA - May 31, 2019

An FDA inspection conducted at Micro-Macinazione SA, a drug manufacturer located in Monteggio, Switzerland, from May 27-31, 2019, resulted in observations documented on Form FDA 483. The inspection highlighted deficiencies in the company hyph s adherence to current Good Manufacturing Practices (cGMP). A primary issue involved inadequate investigations into drug substance quality complaints. From January 2017 to May 2019, the firm received 62 complaints concerning foreign particulates in specific drug substance samples. While the company identified potential sources like cleaning wipes and packaging drums, their investigations failed to assess the broader impact on other active pharmaceutical ingredients (APIs) manufactured using similar processes and equipment. Crucially, corrective actions implemented for the affected drug substance were not extended to these other potentially impacted APIs, demonstrating a lack of comprehensive scope in their quality system. The inspection also revealed that non-dedicated production equipment was not maintained in a suitable state of repair, posing risks of cross hyph contamination. Specifically, investigators observed significant denting in product piping and discharge chutes of systems used for processing multiple APIs, including those destined for the U.S. market. Such physical damage compromises the effectiveness of cleaning processes and the subsequent verification of residue removal, which is critical for preventing product mix hyph ups or contamination during product changeovers. Micro-Macinazione SA is expected to respond to these observations by thoroughly investigating the root causes of each deficiency and implementing robust corrective and preventive actions to ensure full compliance with cGMP regulations and safeguard product quality and safety.