North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding Warning Letter Details

Summary

North American Custom Laboratories, operating as FarmaKeio Superior Custom Compounding, was cited for producing sterile drug products under insanitary conditions that violated current good manufacturing practice requirements and rendered the drugs adulterated under federal law. An FDA inspection from March 1-10, 2022 identified serious deficiencies in the company's sterile drug production practices that put patients at risk, documented on an FDA Form 483. The company voluntarily recalled affected sterile drug products on April 5, 2022, following the inspection findings.