FDA 483 - North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - March 10, 2022

An FDA inspection of North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding in Richardson, TX, revealed significant deficiencies in both sterile and non-sterile drug production. Observations included the use of non-pharmaceutical grade materials, inadequate aseptic processing controls, microbial contamination, and insufficient process validation, indicating serious risks to product quality and patient safety.