FDA EIR - Altasciences Clinical Kansas Inc. - June 07, 2019

An FDA high-priority surveillance inspection was conducted at Altasciences Clinical Kansas, Inc. in Overland Park, KS, from June 3-7, 2019. This comprehensive review, performed under Compliance Program 7348.003 for In Vivo Bioavailability/Bioequivalence Studies (Clinical), assessed the firm's operations related to two key bioequivalence studies: B5381007 for Pfizer and AVG-P2-970 for Alvogen PB Research & Development LLC. The inspection focused on various aspects of clinical trial conduct, including the review of subject records for protocol adherence, adverse event reporting, informed consent processes, and test article accountability. Additionally, the FDA examined the company's procedures for sample collection, processing, storage, randomization, and the integrity of electronic data systems. Crucially, the inspection concluded without the identification of any significant objectionable conditions or violations, as no Form FDA 483 (Inspectional Observations) was issued. Consequently, no specific regulatory actions or formal corrective measures were required from Altasciences. However, during the close-out meeting, management was given a general warning regarding their fundamental responsibility to maintain compliance with the Federal Food, Drug, and Cosmetic Act, noting that any future failure to adhere to these regulations could result in formal regulatory actions. The FDA collected reserve samples of the investigational and reference products from both audited studies as part of its standard procedure.