March 1, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – In a warning letter the U.S. Food and Drug Administration (FDA) slammed Pfizer for dangerous practices at a manufacturing plant in Kansas for drugs made by its Hospira unit, Bloomberg reported this morning.
FDA inspectors found “significant violations of current good manufacturing practice” at the plant during its inspection last year, Bloomberg said. According to the Feb. 14 letter that was just made public, inspectors said Pfizer employees at the plant failed to investigate and explain batch failures. Inspectors said they also found the presence of visible particulates in several sterile injectable products, including the antibiotic vancomycin. Inspectors said those particulates are “an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm to patients.”“The presence of multiple foreign particulates in your products is unacceptable. Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control,” the FDA said in its letter.
The letter said Pfizer received a complaint about the particulates and conducted an inadequate investigation and did nothing. Subsequently, Pfizer received two more complaints and also failed to take action, Bloomberg noted. That particular lot of drugs was ultimately recalled in May 2016, but it was four months after receiving the initial complaint, the letter said.
Pfizer acquired the Hospira plant in 2015 when it bought the company for $15 billion. Pfizer has shut down a number of the Hospira manufacturing sites due to redundancy with its current facilities. Several of those sites were cited by the FDA for issues as well, although many of those took place before Pfizer acquired Illinois-based Hospira.
“These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” the FDA said in its letter.
Pfizer told Reuters that it has been addressing the concerns raised by the FDA in its letter. Additionally, Pfizer said in its statement that the issued raised in the FDA’s letter “do not have any impact on products that are currently on the market that were manufactured at the McPherson site,” Reuters reported.
The warning letter was initially disclosed by Momenta Pharmaceuticals which has its Glatopa product manufactured at that facility, Bloomberg said. The Pfizer facility is a key part of the supply chain for Momenta’s Glatopa products.
Shares of Pfizer are currently trading at $34.44.
