FDA 483 - CFP Acquisitions Inc. - December 08, 2022

CFP Acquisitions, Inc. in Tulsa, OK, a producer of sterile drug products, was cited for significant deficiencies in quality control and aseptic processing during an FDA inspection. Observations included releasing sub-potent drug product, inadequate cleanroom design, lack of dynamic smoke studies, use of non-pharmaceutical grade components, and insufficient media fill simulations. These issues indicate a serious lack of control over critical manufacturing processes.