Bomb Scare Leads to Evacuation at Pfizer Plant

Published: Jun 07, 2017

Bomb Scare Leads to Evacuation at Pfizer Plant June 6, 2017
By Mark Terry, BioSpace.com Breaking News Staff

On Monday, June 5, a Pfizer facility in McPherson, Kansas was evacuated after a bomb threat. In an email to The Wichita Eagle from Pfizer spokeswoman Kim Bencker, all employees were confirmed to be safe.

According to the McPherson Sentinel, at 1:28 a.m. on Monday, the McPherson County 911 received a phone call from an unidentified male who made a threat against the facility. All employees were sent home and the plant did not open for business.

“This is an ongoing investigation and all possible leads are being checked out,” McPherson County Sheriff’s Office Detective Doug Anderson told the Sentinel.

Earlier this year, the McPherson plant came under scrutiny by the U.S. Food and Drug Administration (FDA). The agency indicated that the company’s process for manufacturing sterile injectable drugs was “out of control” and that patients were at risk. The FDA submitted the warning letter on February 14, noting that several products were contaminated with multiple foreign particles. It also said that the “injectable antibiotic vancomycin had been compromised by cardboard pieces.”

In a statement, Pfizer said it had been “diligently implementing commitments made to the FDA” to address the issues.

The letter was in response to an investigation that occurred between May 16 and June 8, 2016. Pfizer acquired the facility in 2015 when it acquired Hospira for $17 billion. In its response, Pfizer said that the FDA letter’s topics “do not have any impact on products that are currently on the market that were manufactured at the McPherson site.”

The FDA, however, indicated that Pfizer’s investigation into the contamination issues was “inadequate” and that similar violations in their manufacturing processes had been seen at other Hospira network facilities over the last several years. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the FDA letter stated.

In May, Pfizer recalled the complete lot of drugs that were potentially contaminated. Bloomberg indicates that the warning letter was disclosed earlier in February by Momenta Pharmaceuticals . Momenta’s Glatopa, a drug for multiple sclerosis (MS), is manufactured at the Kansas plant.

BioPharmaDive wrote in May, “Pfizer has had difficulties bringing Hospira’s manufacturing facilities into compliance with the FDA. The drugmaker’s continued problems come amid stepped-up oversight from the FDA of manufacturing standards, which has impacted approval of a number of drugs in recent quarters.”

“We’re obviously disappointed of the outcome of recent regulatory inspections at some of our manufacturing facilities, including McPherson,” said John Young, head of Pfizer’s Essential Health unit, in a statement to BioPharmaDive. “We are making all of the investments necessary to satisfy the items identified during the recent inspections, and our goal is to have these issues remediated in a timely fashion.”

The McPherson facility is part of Pfizer’s contracting manufacturing business, CentreOne. Since the FDA letter, the company indicates that it has implemented corrective and preventive actions and, according to a statement is “making all the investments necessary to satisfy the items identified during the recent inspections, and our goal is to have these issues remediated in a timely fashion.”

Those investments include capital investments and “exchanging experiences and capabilities across the whole of the Pfizer network,” according to the statement.

Pfizer’s chief executive officer, Ian Read, stated that, “The data in the 483s are based on a view of the plant as a year and a half ago or year ago. So we have made progress. We continue to make progress. And we believe that our plans to rectify those observations are well underway.”

Currently, law enforcement in McPherson County are looking for information and tips about the bomb threat.

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