Prometheus Bio Inc. – FDA EIR, Mar 3, 2017

An FDA inspection of Chinese Peptide Co., Ltd. (CPC) in Hangzhou Zhejiang, China, was conducted from February 13 to March 3, 2017. The inspection, performed under the U.S. regulatory framework, identified critical deficiencies leading to the issuance of a Form FDA 483, Inspectional Observations. Major issues included an inability to verify the authenticity of source data used in clinical studies. Additionally, CPC lacked essential operational procedures, specifically for establishing Institutional Review Boards, ensuring regulatory compliance for Informed Consent, and mandating training for clinical studies and protocols. The absence of device accountability records was also observed. The inspection faced administrative hurdles, including an initial delay due to personnel denying access to records and a company director's refusal to sign an affidavit. Inaccuracies in the firm's USFDA Medical Device Registration and Listing were also noted. In response, Ms. Xu Qi, CPC's President, committed to implementing corrective actions and submitting a written response to the FDA 483 within 15 business days. The company also promised to update its USFDA registration to accurately reflect its facility information.