An injunction against Texas-based prescription and over-the-counter (OTC) drug contract manufacturer Deltex is forcing the firm to shut down operations and recall all products manufactured since it received an FDA warning letter in 2008.
The injunction followed in the wake of recurrent GMP problems at the firm centering around laboratory controls and a failure to heed agency warnings on the marketing of unapproved new drugs. The two areas of concern were targeted in the 2008 warning letter and highlighted in the consent decree.
Both the failure to meet lab GMP requirements and to discontinue or file applications for unapproved new drugs have been key focal points on FDA’s enforcement radar screen over the past few years.
The agency has clearly shown in its recent compliance actions that the marketing of unapproved drugs will escalate the agency’s response when GMP problems are found, and the Deltex situation provides another case in point. [Editor’s note: This connection between unapproved drugs and GMP problems in FDA’s enforcement activity is explored by IPQ in its May/June 2009 Report. Also see IPQ “In the News” October 8, 2010 and October 28, 2010 for additional related coverage.]
Several of the unapproved drugs FDA found Deltex to be marketing were cough/cold medications that contained active ingredients or combinations of those ingredients targeted in the agency’s most recent industry-wide action under its four-year old unapproved drugs initiative.
In early March, the agency announced in the Federal Register its intention to take enforcement action against approximately 500 prescription cough/cold products “marketed without approved applications,” many of which are “inappropriately labeled for use in infants and young children.” [See the IPQ “In the News” companion story March 9].
[More on the Deltex GMP and unapproved drug problems leading to the injunction is provided for subscribers here. Non-subscribers can purchase the story for $95 by contacting Peter Blachly (Peter@ipq.org). For subscription/license information click here.]