FDA EIR - Charles River Laboratories Cleveland, Inc. - July 16, 2010

An FDA inspection of Chantest Inc., a Cleveland-based in-vitro non-clinical test facility specializing in drug safety and discovery services, was conducted from July 12-16, 2010. The unannounced inspection, directed by GLP regulations (21 CFR Part 58), focused on a data audit of pharmacology safety data related to human drugs. The primary violation documented on FDA Form 483 concerned inadequate protocol documentation. Specifically, for Study (b)(4), a critical change in test article concentration was implemented in a Phase I assay without a documented and approved protocol amendment or deviation. Inspectors also noted instances where protocol amendments for other studies were signed after the effective date, indicating changes were executed before formal approval by the study director. Furthermore, the inspection highlighted an outdated master schedule with several studies pending finalization for years, and concerns were raised about the data security and audit trail capabilities of the firm's (b)(4) software system. In response, Chantest Inc. issued a report amendment and protocol deviation for the identified study during the inspection and stated they implemented new procedures to prevent recurrence. The company also closed nine outstanding studies and committed to updating its master schedule. Critically, Chantest Inc. provided a written commitment to the FDA outlining plans to enhance data security for its (b)(4) software system within (b)(4) days, including (b)(4).