Triangle Compounding Pharmacy Inc – FDA 483, Jan 16, 2015

This FDA Form 483 document outlines observations made during an inspection, indicating a failure to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile.

Specifically, four observations were noted: 1. The quality unit did not appropriately review the results of aseptic process simulations for all sterile processing technicians, dated October 20, 23, 24, and November 10, 2014. This was in contravention of the "Quality Assurance Program" policy, effective September 3, 2013. 2. Non-sterile wipes are utilized to clean inside the ISO 5 personal workplace hood area, as detailed in standard operating procedure (SOP) 5.161, "Clean Room Routine Maintenance," effective January 5, 2015. 3. There is no SOP delineating the disinfection of the non-viable particle counter device, which is placed inside the ISO 5 personal workplace hood area and transported from ISO 7 and ISO 8 areas. 4. Active air samples for viables are not collected inside the ISO 5 personal workplace hood area as part of the current environmental monitoring program, as delineated in SOP 7.110, "Environmental Monitoring," effective October 1, 2014.

These observations highlight deficiencies in quality unit oversight, cleaning procedures, equipment disinfection protocols, and environmental monitoring within