FDA 483 - Claremore Compounding Center, Inc. - January 24, 2020

Claremore Compounding Center, Inc. in Claremore, OK, a producer of non-sterile drug products, was cited for three significant issues during an FDA inspection. The firm used non-pharmaceutical grade components, lacked a written stability testing program for drug product expiration dates, and failed to conduct routine potency testing before releasing drug products. These observations indicate serious deficiencies in quality control and manufacturing practices.