FDA 483 - Triangle Compounding Pharmacy Inc - April 04, 2019

During an FDA inspection from March 26, 2019, to April 4, 2019, Triangle Compounding Pharmacy Inc., a producer of sterile drugs located at 3700 Regency Pkwy Ste 140, Cary, NC, was issued a Form FDA 483. The report was addressed to Danny M. Barnes, President and Chief Pharmacy Officer.

The sole observation noted was that drug product was prepared using a manufacturing method that does not assure it meets requirements for safety, identity, strength, quality, and/or purity. Specifically, up to an average of approximately 10.9% of some product lots compounded in vials from the firm's chosen supplier contained foreign matter, including light particles, dark particles, and fibers. Particulate matter was observed in vials of finished drug units and during aseptic process simulations (4 out of 4 simulations reviewed showed 2% to 9.8% particulate matter). Although finished drug units identified with particulate matter were destroyed, the firm continued to use vials from the supplier, despite identifying them as the primary source of particulates. This indicates a critical deficiency in quality control and manufacturing processes, potentially impacting the safety and purity of dispensed drugs.