FDA 483 - Wedgewood Connect, LLC - December 19, 2018

An FDA inspection of Leiter's Enterprises, Inc., an outsourcing facility located at 17 Great Oaks Blvd, San Jose, CA, was conducted from December 10-19, 2018. The inspection, led by Investigator Ashar P Parikh, resulted in three observations documented on Form FDA 483.

Observation 1 noted that the responsibilities and procedures for the quality control unit were not in writing and fully followed. Specifically, the firm's management of the building monitoring system alarms lacked adequate quality control review, with no established timeframes for timely alarm review and no requirement for quality control to review alarm acknowledgements.

Observation 2 identified deficiencies in employee training for drug product processing. Visual inspectors of filled drug products were not required to take a break unless they had inspected a redacted number of units for a redacted duration. The qualification process, requiring inspectors to identify at least a redacted percentage of defects in a redacted number of units during redacted visual inspection qualifications, was deemed inadequate to ensure consistent defect detection throughout the entire redacted visual inspection process.

Observation 3 cited deficiencies in the aseptic processing areas regarding the system for cleaning and disinfecting equipment. The firm did not routinely clean the wheels of chairs and rolling carts in the ISO 7 cleanroom, despite their movement during operations, as observed on December 12, 2018. The firm's SOP 3.020 "Cleaning and Disinfection of ISO 7