Pfizer McPherson site hit with US FDA repeat observations

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty Bakhtiar_Zein)
(Image: Getty Bakhtiar_Zein)

Related tags: Pfizer, Hospira, Fda

Pfizer’s sterile drug manufacturing site in Kansas received eight observations during an FDA inspection.

Following its acquisition of Hospira in 2015, Pfizer has had to take significant action​ to manage the problematic manufacturing network it inherited.

The US Food and Drug Administration (FDA) has highlighted the work still to be done, with a number of repeat observations made at Pfizer’s McPherson-based site.

The FDA inspection was carried out between July 23 and August 8, 2018 – with the agency noting eight observations of issues to address. All but one of the observations reported by the agency had been noted previously during plant inspections.  

Among the repeat observations was the failure to review discrepancy between batches, and not following adequate aspect processes.

The fill and finish site has suffered a number of regulator setbacks since the completion of the acquisition. Earlier this year​ products produced at the site were recalled due to cracks being found on the rim surface of vials.

A spokesperson for Pfizer provided us with a statement addressing the issues: “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. 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 statement continued.

In third quarter financials​, Pfizer outlined that the manufacturing issues the Hospira business were facing were a significant contributing factor to the operational decline in the company’s sterile injectables portfolio.

However, outgoing CEO​, Ian Read, suggested that such problems would “would significantly improve by the end of 2019.”

Related topics: Regulatory & Safety, Regulations, QA/QC

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