Just when you thought it couldn’t get any worse for the manufacturer of Excedrin, it has.
In a newly-released inspection report, the Food and Drug Administration found that Novartis repeatedly failed to take adequate steps to investigate or correct problems at its troubled Lincoln, Nebraska plant.
If that sounds like déjà vu all over again, it’s because it is.
An earlier FDA inspection in 2011 found that Novartis failed to adequately investigate hundreds of consumer complaints of foreign products found in bottles of Excedrin and other over-the-counter medications produced at Lincoln. The plant was eventually shutdown to correct manufacturing problems, leading to shortages of Excedrin products around the world.
After several missteps and millions of dollars spent re-tooling the plant, Novartis slowly re-launched Excedrin Migraine in November, 2012, followed by Excedrin Extra Strength in January of this year.
Last week, Novartis (NYSE: NVS) said it would it “simplify” operations at the plant by eliminating 300 jobs, or 40% of the workforce. Only three products — Excedrin, Theraflu and Sentinel painkiller for pets — would be manufactured there. The rest of the product line would be shifted to third-party manufacturers.
The latest FDA inspections – made in January and February of this year – may explain why Novartis is downsizing at Lincoln.
FDA inspectors randomly investigated nine customer complaints (out of 1,066 cases) that had already been addressed by the plant’s newly formed quality control unit. They found that in all nine cases the company failed to take adequate steps to address manufacturing problems.
Among those observations:
- Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other products that may have had the same problem.
- Written records of investigations did not always include the quality control units’ conclusions and follow ups.
- The responsibilities and procedures of the quality control unit were not fully followed.
- Storage systems did not provide adequate protection against deterioration or contamination of drug products.
“These examples are significant because the investigations were recently closed and are indicative of how your firm currently handles consumer complaints,” the FDA inspectors wrote. “Your quality unit has failed in the responsibility and authority to monitor quality systems designed to assure the quality of drug products manufactured and packaged at your firm.”
In one instance, investigators noted that after a one-year-old child opened and drank a bottle of Triaminic with a child-resistant cap, the quality control unit closed its investigation after just one week — failing to extend the investigation into dozens of other child resistant containers that were also found to be defective.
According to the FDA report, the plant’s control unit concluded that “No actions are necessary at this time due to an unknown lot number and a downward trend in the Product Family.”
“This statement is contradictory to known facts in your firm during this time,” FDA inspectors wrote.
In January, Novartis recalled over two million bottles of Triaminic and Theraflu after four children opened the child-resistant caps and ingested the medication.
Novartis made no mention of these specific problems in a statement released last week.
“The Lincoln site has made significant progress since the production suspension,” Novartis said in the statement. “However, we still have more remediation work to do. Novartis Consumer Health is working hard to deliver the quality consumers expect and deserve and to ensure the integrity and safety of the products we manufacture.”
“We are taking the necessary corrective actions to address the FDA’s observations and build on the progress we’ve made in many areas of site operation and quality systems,” the company said.
The latest report comes on the heels of the Swiss pharmaceutical giant being slapped with two federal lawsuits alleging illegal kickback schemes aimed at enticing doctors into prescribing its drugs. The company spent millions of dollars on social events for physicians, including fishing trips and dinners at Hooters restaurants.