FDA 483 - ABC Pharmaceuticals - December 20, 2019

An FDA inspection of ABC Pharmacy, Inc. in Encino, CA, a producer of non-sterile drug products, revealed two significant observations. The firm was cited for releasing drug products that did not meet strength or purity specifications and for dispensing products beyond their assigned beyond-use dates. Additionally, the inspection noted inadequate cleaning practices for utensils used in hazardous drug production, posing a risk of cross-contamination.