Troubled Pfizer plant faces more criticism in Form 483
- Though Pfizer has said it's on the path to resolving legacy manufacturing issues at its McPherson, Kansas-based facility, the problems keep rolling in. The latest is a Form 483 stemming from a Food and Drug Administration inspection this summer.
- The two-week-long inspection found eight observations, seven of which have been problematic as far back as 2012. These include failures to review unexplained discrepancies, not submitting a field alert report, violations with sterile and testing processes, and lack of staff training.
- The Food and Drug Administration has not yet issued any determination regarding compliance based on this investigation.
Pfizer completed its acquisition of Hospira in 2015, bringing in-house the McPherson plant. From a regulatory perspective, the facility has been a thorn in the big pharma's side for the company ever since.
The mid-2018 inspection indicates the plant still isn't up to the FDA's standards. Product residue as a potential source of contamination was found in July in the same place as it was discovered in December 2017. Investigators also noted a failure to adequately look into nine cases of an unknown gel in a HEPA filter; employees not submitting FDA field alert reports; and the potential for contamination of sterile products and for release of hazardous material.
Additionally, the report claimed the facility lacked employee training in the manufacture, processing, packing, and holding of a drug product.
A previous warning letter issued in February 2017 was sharp, noting that the presence of foreign contaminants was unacceptable and posed a "significant risk" to patients.
Not surprisingly, last year was dogged with withdrawals. The trend continued into 2018, with recalls of labetalol hydrochloride injection vials that had been manufactured at the plant in March. These vials had cracks on the rim surface, which could result in sterility issues.
Manufacturing violations at the facility led to an FDA rejection for Pfizer's Epogen/Procrit (epoetin alfa) biosimilar, Retacrit, in June 2017. The following February, regulators gave the McPherson plant a Voluntary Action Initiated classification, meanings its compliance problems weren't serious enough to stop drugs from gaining approval.
The issues at the McPherson plant have reduced the supply of injectable opioids with delays expected until 2019.
Pfizer has spent somewhere around $300 million on production line upgrades, according to a report from Brigham Young University.
- BioPharma Dive Pfizer Hospira plant faces another recall
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