FDA EIR - Veranova LP - January 31, 2019

Johnson Matthey Pharma Services underwent an FDA inspection from January 23 to 31, 2019. This comprehensive review, conducted under the Active Pharmaceutical Ingredient (API) Process Inspections program, focused on Quality, Facilities and Equipment, Production, and Materials Systems, and also served as a follow-up to a prior 2016 inspection. The 2016 inspection had identified issues, including the Quality Unit's failure to adequately complete Annual Product Reviews and deviation investigations within appropriate timeframes, and inconsistent documentation of laboratory equipment calibration. During the 2019 inspection, these previously noted deficiencies were confirmed to have been successfully corrected by the company. Significantly, the 2019 inspection concluded without the issuance of an FDA Form 483, indicating no major violations. The only discussion item concerned the firm's purified water system procedures, which lacked clear definitions for the frequency of sampling and testing for conductivity, Total Organic Carbon (TOC), and microbial analysis. Johnson Matthey demonstrated a proactive response by voluntarily updating its procedures during the inspection to address this point, thereby specifying the required testing frequencies.