FDA WARNING_LETTER - Wedgewood Connect, LLC - March 06, 2014

The FDA issued a Warning Letter to Leiter's Cambrian Park Drugs, Inc. dba Leiter's Compounding following inspections from October 22, 2013, to November 5, 2013, and February 18, 2014, to March 6, 2014, at their 1700 Park Ave, San Jose, CA facility. The inspections revealed the firm produced drug products without valid prescriptions for individually-identified patients and compounded domperidone, which is not subject to an applicable USP/NF monograph, is not an FDA-approved drug component, and is not on a Secretary-developed list under FDCA section 503A(b)(1)(A)(i)(III).

Serious deficiencies in sterile drug product practices were observed, including failure to investigate sterility test failures and an operator wearing eye cosmetics without protection and with exposed skin in the cleanroom while filling injectables. These practices put patients at risk.

The FDA cited violations of the FDCA, classifying the drugs produced without valid prescriptions and domperidone products as unapproved new drugs (sections 505(a) and 301(d)) and misbranded drugs (sections 502(f)(1) and 301(a)). Additionally, sterile drug products were prepared under insanitary conditions, rendering them adulterated (section 501(a)(2)(A