FDA EIR - Eurofins PROXY Laboratories B.V. - September 16, 2016

A comprehensive cGMP inspection by the FDA was conducted at PROXY Laboratories B.V. in Leiden, Netherlands, from September 15-16, 2016, focusing on their analytical and stability testing operations under drug manufacturing guidelines. The inspection revealed four key areas of concern. Firstly, significant data integrity issues were identified. Numerous laboratory instruments, including UV Spectrometers and GCs, lacked essential controls such as unique user logins, user management systems, and audit trails, leaving electronic data susceptible to unauthorized access or alteration. Secondly, the quality control unit's procedures were inadequate. There were no established criteria for classifying changes, deviations, out-of-specification or out-of-trend results, and complaints, nor for escalating issues to the management board. Furthermore, specific analytical method transfer procedures were missing. Thirdly, complaint handling was deficient. The inspection found 204 complaints from the "510" series that had not been investigated, with no written justification provided. Criteria for classifying complaints as critical, major, or minor were also undefined. Finally, laboratory equipment monitoring was insufficient. Temperature-controlled storage units for reagents, chemicals, and samples were not consistently monitored at their hottest and coldest locations, posing a risk to product integrity. The company's Managing Director committed to addressing these deficiencies with a written response to the FDA within 15 business days.