FDA 483 - Southern California Compounding Pharmacy, LLC - August 01, 2019

An FDA inspection of Southern California Compounding Pharmacy, LLC in San Diego, CA, revealed significant deficiencies in aseptic processing, environmental controls, and laboratory testing for both sterile and non-sterile drug products. Observations included inadequate personnel and environmental monitoring, poor gowning and aseptic practices, and deficient cleaning procedures. The firm also failed to conduct an adequate smoke study and did not test finished non-sterile drug products for microorganisms.