Since Pfizer’s Kansas plant received an FDA warning letter last year, the company has insisted it is making good progress on turning things around at the essential but troubled injectables facility. But the findings from the most recent inspection show that not only do problems persist, but most of them the FDA had flagged before.
The 10-page Form 483 is from a two-week inspection of the Hospira facility in late July and early August, and it suggests an operation that just can’t learn from its past mistakes. Of the eight observations, seven of them are repeats, some noted at least twice before. It is a failing that a frustrated FDA lamented in its warning letter to the company last year.
Still, Pfizer again says things really are getting better.
“Following the July-August 2018 inspection, the site developed and implemented a robust corrective and preventive action plan to address FDA observations noted during the inspection,” Pfizer said today in a statement. “While there is still additional work to be done against our plan, the site has made significant improvements and progress since the inspection.
“We will continue to focus on executing improvements at the site and bringing safe and effective medicines to our patients. In the interim, our site remains in operation and we stand behind the products manufactured there.”
The inspection report also sheds some new light on the difficulties the plant has faced, including the fact that at this time last year, it had to suspend production in a filling area after finding mold contamination, a situation that resulted in the rejection of four batches. The plant’s investigation decided the problem was tied to dried residue and passed it off as poor cleaning. But the FDA said the investigation was not nearly thorough enough and that employees did not identify the residue or establish a root cause for the problem.
Other observations showed the plant falling far short of taking all of the steps needed to identify and resolve issues once and for all.
The problems at the McPherson plant have taken a significant financial toll on the company. Pfizer lowered its 2018 guidance range to $53.7 billion on the top end from $55 billion, with exiting Pfizer CEO Ian Read blaming it largely on “lower-than-anticipated Essential Health revenues, primarily due to continued legacy Hospira sterile injectable product shortages in the U.S.” and changes in foreign exchange rates. He predicted the issues would be resolved by the end of 2019.
But those shortages have also taken a toll on patient care in the U.S. Hospira is the largest producer of injectable opioid analgesics used in hospitals, and hospitals have had a hard time getting what they need. The FDA has blamed shortages of essential products on the plant’s ongoing revamping efforts and said they were “exacerbated by recent issues related to manufacturing quality at the same facility.” The FDA has been working with Pfizer and other drugmakers to deal with the shortages. Pfizer has said it will be next year before clients can expect to see the situation resolved.