ImprimisRx NJ – FDA Warning Letter, Aug 19, 2013

On June 23, 2014, the FDA issued a Warning Letter to Pharmacy Creations following an inspection from August 5-19, 2013. The inspection revealed the firm was producing drug products without valid patient-specific prescriptions and continued to make domperidone drug products despite prior warnings in 2006 and 2008. Domperidone is not subject to an applicable USP/NF monograph, is not an FDA-approved human drug component, nor is it on a Secretary-developed list under FDCA section 503A(b)(1)(A)(i)(III).

The FDA also observed serious deficiencies in sterile drug product manufacturing, including producing sterile injectable drugs in multiple-dose containers without preservatives, increasing infection risk. The firm also produced lyophilized epinephrine without demonstrating the process prevents microbial contamination or ensures consistent potency. These issues were noted on a Form FDA 483.

The compounded drugs without valid prescriptions and those containing domperidone are considered unapproved new drugs and misbranded drugs, violating FDCA sections 505(a) and 502(f)(1). Furthermore, the firm committed significant Current Good Manufacturing Practice (CGMP) violations, causing drug products to be adulterated under FDCA section 501(a)(2)(B). Repeat CGMP violations from a 2006 warning letter included failures in stability testing, process control, environmental monitoring