FibroGen Incorporated – FDA EIR, Sep 19, 2014

An FDA for-cause inspection of FibroGen Incorporated was conducted from September 8 to 19, 2014, under the Good Clinical Practice regulatory framework (Compliance Program 7348.810). This comprehensive BIMO inspection, triggered by a complaint, focused on clinical trials for investigational drugs under INDs (b)(4) and (b)(4). The inspection revealed significant issues, leading to the issuance of a Form FDA 483, Inspectional Observations, to the CEO. The primary violation cited was FibroGen's failure to conduct a study in accordance with its protocol. Specifically, the company allowed inclusion criteria deviations for subject enrollment without first amending the protocol, informing the FDA, or obtaining Institutional Review Board (IRB) approval for these changes. Additional concerns raised included the repeated late submission of FDA annual reports for two Investigational New Drug (IND) applications, initial reporting of study information on clinicaltrials.gov more than 21 days after the first subject's enrollment, and a notable absence of Standard Operating Procedures (SOPs) for various critical Good Clinical Practice functions, such as vendor qualification and the timely reporting of new investigators to the FDA. FibroGen's management acknowledged the observations and committed to implementing corrective and preventive actions, promising a written response to the FDA by October 10, 2014.