FDA 483 - Pyramid Laboratories, Inc. - April 11, 2019

An FDA inspection of Pyramid Laboratories, Inc. in Costa Mesa, CA, a sterile drug manufacturer and contract test laboratory, revealed significant deficiencies in their laboratory control systems. The firm failed to adequately quantitate and evaluate impurity levels for G-Pen Glucagon Injection 5 mg/mL. This included a lack of appropriate release specifications for impurities and insufficient validation of the test method used for impurity content.