FDA DISCOVERED SERIOUS ISSUES AT SPECIALTY COMPOUNDING, LLC in CEDAR PARK TX DURING MARCH INSPECTION; 483 Report Available Here

By Sue Tuck Richmond
August 14, 2013

Specialty Compounding, LLC in Cedar Park, TX was inspected by the FDA in March 2013.  A form 483 was issued after the facilities.  Investigators cited a number of problems relating to contamination and sterility.  The 483 states, "[p]rocedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established."  The inspectors observed that  pharmacists in the facility were not following proper procedures to ensure sterility. This included pharmacist wiping exposed areas of the skin without changing gloves before continuing work and a pharmacist crawling on the floor to retrieve a vial without re-gowning or changing gloves before handling components like vials, syringes, and IV bags.  The inspectors also indicated in the 483 that the facility lacked proper validation of sterilization procedures and processes.  The FDA inspectors also stated in the 483 that the pharmacy was not conducting routine sterility testing for all of their injectable drugs.   They also observed that the aseptic processing areas were “deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.”

The  entire 483 can be read here