Generic drug maker shuttered for alleged FDA violations
A room used to perform annual inspections of pharmaceutical products for visual signs of deterioration was so dark that federal investigators had to use flashlights to inspect the drugs. Samples of Thiamine Hydrochloride, Lidocaine Hydrochloride, and Phenylbutazone were found by U.S. Food and Drug Administration (FDA) inspectors to contain particles, because the drug company employees originally charged with the inspections had no training.
Missouri-based veterinary drug company Teva Animal Health Inc., has been shut down by the federal government due to these and other alleged “significant” violations of current Good Manufacturing Practice (cGMP), according to legal documents obtained by NEWStat.
The U.S. Food and Drug Administration (FDA) said in an announcement that it has filed a consent decree of permanent injunction against Teva Animal Health Inc. A “consent decree of permanent injunction” is a court order that enjoins a firm or individuals from continuing a specific violation. The injunction prevents Teva Animal Health, its president, and two principals from its parent company from manufacturing and distributing adulterated veterinary drugs, the FDA said.
It was unclear when the company would resume operations, but the FDA said the company cannot begin manufacturing and distributing veterinary drugs again “until adequate methods, facilities, and controls are established and an independent expert inspects the facilities and procedures and certifies that they comply with cGMP.”
According to the agency, three separate FDA inspections between 2007 and 2009 “found significant cGMP violations at Teva Animal Healths facilities, located in St. Joseph, Mo.” The violations are detailed in the lawsuit and an observation report, copies of which were obtained by NEWStat.
The violations range from general quality control problems such as failure to reject drug products that do not meet established specifications; to laboratory issues like inadequate lighting in the retention sample room. In one observation, the FDA said their inspectors had to use flashlights to see the reserve samples in a room that the company uses “to conduct visual examinations during investigations and annual review of products for visual signs of deterioration.”
Other violations (from the 2009 inspection) included:
- failure to conduct a thorough investigation of drug products that do not meet their specifications, including the failure to extend an investigation to other batches of the same product and other products that may have been associated with the specific product failure;
- failure to validate the manufacturing process for certain drug products to assure that the products have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to conduct adequate finished product testing on Xylazine and Epinephrine to assure that they conform to specifications;
- failure to assure the reliability of test methods used to assess the stability characteristics of drug products;
- failure to retain sufficient samples of drug products to perform required testing and failure to conduct a visual examination at least once a year of samples for evidence of deterioration;
- failure to document the accuracy, sensitivity, specificity, and reproducibility of the assay method for Lidocaine USP; and
- failure to provide adequate training for employees to enable them to perform their assigned functions.
The FDA said it filed the injunction because Teva officials refused to make changes that the agency required following its inspections. The full list of observations can be found here.
“The defendants have shown that they are unwilling or unable to take the necessary steps to prevent recurrence of CGMP violations,” the suit says. “For example, despite the defendants’ attempts to correct their CGMP violations, during the 2009 inspection, the FDA investigators observed that the defendants continue to manufacture animal drugs in a manner that does not comply with CGMP.”
A company spokeswoman said Teva has acknowledged the injunction and is taking steps to correct the problem.
“Teva Animal Health regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements,” said Denise Bradley, Teva Pharmaceuticals senior director of North America corporate communications. “These actions include conducting a complete analysis of each individual product; retraining all of our production employees, and revalidating our equipment, processes and methods.”
Bradley said there have been no product recalls issued at this time, and the company had no further comment on the issue.
According to its website, Teva Animal Health is the largest manufacturer of generic animal pharmaceuticals in the United States. The company also makes dermatological preparations, nutraceuticals and specialty products with the brand name DVM Pharmaceuticals.
If consumers have questions or concerns with purchased product or seek to return the products, they should contact either place of purchase or Teva Animal Health, an FDA spokeswoman said.