FDA 483 - Medscript Compounding Pharmacy - July 17, 2019

D&D Pharma, LLC dba MedScript Compounding Pharmacy in Noblesville, IN, was inspected and cited for significant deficiencies in aseptic processing. Observations included inadequate response to microbial contamination in cleanrooms and the use of uncalibrated equipment for critical testing. Additionally, the firm failed to properly disinfect materials entering aseptic areas and did not certify ISO-5 classified areas under dynamic operational conditions.