Albert Browne Ltd. – FDA EIR, Sep 12, 2019

A compliance follow-up inspection of Albert Browne Ltd., a UK-based manufacturer of chemical indicator strips, was conducted from September 9-12, 2019. The inspection aimed to verify corrections to previous findings that led to a Warning Letter in 2012 and to conduct a comprehensive quality systems review under the regulatory framework of Compliance Program 7382.845 for Medical Device Manufacturers. All observations from the prior inspection were found corrected, and no formal inspectional observations (Form FDA 483) were issued during this visit. However, three discussion items were identified at the close of the inspection, requiring management's commitment to address them. These included deficiencies in their internal audit process, such as inconsistent documentation of auditor qualifications and, in one instance from FY17, auditors reviewing areas for which they held direct responsibility. Additionally, the firm's complaint handling procedure was found to be outdated, lacking clear guidance for assessing reportable events, and not all complaints were logged into their system, impacting data accuracy for trending. Finally, their nonconformance procedure lacked definitions for product disposition terms like "Void," and an investigation into a specific nonconformance was initiated but not completed. Although no formal violations were cited, these areas necessitate improvements to Albert Browne Ltd.'s quality system procedures to ensure ongoing compliance.