After nine failed inspections over the course of 11 years, a California-based drug and supplement manufacturer has been ordered to halt its operations.
U.S. District Court Judge Otis D. Wright signed an injunction order against Titan Medical Enterprises for manufacturing and distribution unapproved drugs and adulterated dietary supplements and for repeated violation of the Food, Drug & Cosmetic Act. According to Wright’s Statement of Decision, the injunction order came at the behest of a U.S. Department of Justice (DOJ) complaint filed on Dec. 28, 2011.
The U.S. Food & Drug Administration (FDA) requested the DOJ complaint after a decade of inspections into Titan’s operations revealed multiple violations of drug and dietary supplement cGMP requirements. According to an FDA press release:
Nine FDA inspections of Titan between 2001 and 2012 revealed that the company’s drugs were not manufactured and distributed in compliance with Drug cGMP. Violations included failure to establish an adequate written testing program to assess the stability of finished products and failure to establish and follow adequate laboratory controls.
The majority of the inspections related to Titan’s drug manufacturing, while the three most recent scrutinized the company’s dietary supplement business:
FDA inspections in 2010, 2011, and 2012 revealed that Titan violated the Dietary Supplement cGMP regulations by, among other things, failing to verify that a subset of finished dietary supplement batches met product specifications and failing to adequately confirm the identity of dietary supplement components.
FDA has made GMP enforcement a priority over the past few years, and has requested and received a handful of permanent injunctions against repeat offenders. Recently, certain manufacturers in Minnesota, Oregon and Pennsylvania have been shuttered by injunctions.
What took so long?
The outstanding question, though, is why it took 11 years and nine inspections to shutter Titan.
“Under normal circumstances, FDA operates at a glacial speed,” said attorney Marc Ullman, of Ullman Shapiro & Ullman. “And I know that we had eight years of an administration where all regulatory enforcement was low-priority.” But over a decade of persistent violations begs the question of FDA’s regulatory efficacy.
It could be that quashing Titan was low on the enforcement agenda until supplement GMP violations came into the picture. Now that Dr. Daniel Fabricant, head of FDA’s Division of Dietary Supplement Programs, has made GMP enforcement a higher priority, perhaps the agency was finally able to take action that was several years in the making.
Whatever the reason for the delay, manufacturers best be warned that FDA is on the war path for GMP offenders. Injunctions are hitting left and right, and according to Ullman, “Dr. Fabricant has said there are more in the pipeline.” A quick buck is worth its weight in legal fees down the road.