FDA 483 - Triangle Compounding Pharmacy Inc - September 22, 2014

An FDA 483 document was issued to Triangle Compounding, an outsourcing facility located in Cary, NC, following an inspection conducted from September 8 to September 22, 2014. The inspection revealed several critical deficiencies indicating non-compliance with federal drug manufacturing regulations and specific requirements for outsourcing facilities.

Main violations included a systematic failure to thoroughly investigate sterility failures, with inadequate root cause analysis and a lack of implemented corrective actions to prevent reoccurrence. Complaint records were found to be deficient, as investigations into adverse drug experiences were not comprehensively conducted or evaluated for potential MedWatch reporting. The facility also failed to adhere to procedures designed to prevent microbiological contamination, specifically lacking routine microbial sampling of personnel gowning during sterile product processing.

Further issues comprised insufficient laboratory controls, such as the absence of training for 100% visual inspection of sterile products and a lack of established methods to evaluate preservative effectiveness. Triangle Compounding accepted component supplier analyses without validating their reliability and did not follow its written stability testing program for sterile drug products. Additionally, there was an absence of written procedures for the management of labeling and packaging materials, and drug product labels were non-compliant with section 503B(a)(10)(A)&(B), missing crucial information like inactive ingredient lists and adverse event reporting details. The company is required to implement comprehensive corrective actions to address all observations and achieve full compliance with federal regulations governing sterile drug manufacturing and labeling.