The Combination of GMP & Unapproved Drug Problems Continues to Prompt FDA Warning Letters

Warning letters to a pair of over-the-counter (OTC) drug manufacturers just released by FDA indicate that the marketing of unapproved drugs continues to escalate the agency’s response when GMP problems are found.

An April letter to Capricorn Pharma (Frederick, Maryland) and a September letter to Absolute Packaging (Melbourne, Florida) both addressed GMP issues at the firms as well as their marketing of unapproved drugs.

At Capricorn, the GMP problems cited involved:  ● releasing product prior to generating data to support expiry dating ● failure to reject tablets that were out-of-specification (OOS) for hardness ● failure to investigate OOS results during process validation ● issues with cleaning validation including level of product residue and swab recovery ● storage and control of retention samples, and ● security of lab computer systems.  The stability data, OOS rejection and cleaning validation observations were repeats from a 2008 inspection, the letter notes.

In the section of the letter addressing “unapproved OTC drug product violations,” the agency cites Capricorn for marketing the active ingredient guaifenesin in a dosage form not covered by FDA’s ongoing OTC drug review process.

[ More on the recent warning letters and on FDA’s unapproved drugs initiative and its relationship to GMP enforcement activities are available for subscribers here.  For subscription information, click here. For an extended analysis of the linkage between unapproved drugs and GMP problems in FDA’s recent enforcement activity see the IPQ May/June 2009 Report .]