FDA 483 - Wedgewood Connect, LLC - December 03, 2021

An FDA inspection of Wedgewood Connect, LLC, an outsourcing facility in San Jose, CA, was conducted from November 16 to December 3, 2021. The inspection revealed four observations regarding the firm's quality control, investigation procedures, sterile product contamination prevention, and equipment maintenance.

Observation 1 noted that the quality control unit's responsibilities and procedures were not fully followed. Specifically, there was no written procedure for assessing and disposing of critical reject units from aseptic media fills, with 30 batches having rejected units not submitted for assessment. A lack of SOP for the (b)(4) led to black particles in Cyclosporine 2% Ophthalmic Suspension. Additionally, the firm failed to initiate CAPAs for customer complaints regarding particles (7 complaints) and clogged bottles (17 complaints) in sterile ophthalmic products in a timely manner.

Observation 2 highlighted a failure to thoroughly review unexplained discrepancies. The firm did not investigate root causes for 10 complaints of particles and 18 complaints of clogging in Cyclosporine 2% in Corn Oil Ophthalmic Solution, 1 complaint of particles in Apomorphine HCl Injection Solution, and 1 complaint of clogging in Tacrolimus 1% in MCT Oil Ophthalmic Solution. Furthermore, there was no investigation into a non-integral unit identified during in-process evaluation of media fill units, and no written procedure for identifying or assessing such units.

Observation 3