FDA EIR - Gene Logic, Inc. - September 27, 2019

The FDA conducted a comprehensive Good Laboratory Practice (GLP) inspection of Gene Logic, Inc. in Gaithersburg, MD, from August 30 to September 12, 2005. Operating under the regulatory framework of 21 CFR Part 58, this inspection followed up on a previous October 2003 inspection and a January 2005 Warning Letter. The prior letter highlighted deficiencies such as inadequate testing and reporting of test article stability and strength, incomplete final reports lacking crucial data and analysis, and failures in protocol approval and archive transfers.

The 2005 inspection identified new issues, leading to a four-item Form FDA 483. Main violations included the failure to integrate contributing scientists' reports into final study reports, properly document and approve protocol amendments in advance, thoroughly describe all circumstances affecting data quality or integrity, and include all data transformations and calculations in final reports. Additional discussion points addressed study director assignments and animal age documentation.

In response, Gene Logic's management committed to providing a written response to the FDA 483 observations with specific corrective action dates by September 26, 2005, and an update by October 12, 2005. The FDA emphasized potential regulatory actions, including further warning letters or legal injunctions, if compliance issues persisted.