Updated: FDA Flags Pfizer’s Hospira Plant in Kansas Over Repeat 483 Citations

Regulatory NewsRegulatory News | 07 December 2018 |  By 

A US Food and Drug Administration (FDA) inspection at the McPherson, KS plant of Pfizer’s Hospira business revealed seven repeat FDA Form 483 citations dating back to 2012.

FDA investigators conducted an inspection of the human sterile drug manufacturing site from late July to early August 2018, with the agency posting the Form 483 to its website Friday. The latest 483 comes after Hospira’s Kansas plant drew an FDA warning letter last year, with significant violations of good manufacturing practices, such as an inadequate investigation into the detected presence of cardboard in vial samples.

The newly cited 483 observations that have lingered since 2012 relate to inefficient procedures around preventing a drug that is purporting to be sterile from being contaminated, and a failure to submit a new drug application (NDA) field report within three working days after detecting or becoming aware of a failure in meeting established specifications in one or more batches of a drug.

The firm’s site was observed to have detected mold, “a potential data integrity event associated with an in-process auditor” in 2017 and 2018, but it failed to submit an NDA field report within the required timeframe, according to the 483. Pfizer also did not submit a field alert report after it “discovered a cracked needle hub (critical A defect while performing a manufacturing quality audit of Morphine Sulfate Inj. USP, lot #80740LL” from 2017 until 5 February 2018.

FDA also flagged ongoing quality manufacturing issues regarding inefficient aseptic processing areas and failures to conduct thorough investigations into discrepancies in batches of finished products. The firm had “failed to adequately investigate approximately 9 previous events when an unknown foreign material/gel was observed adhering to the High Efficiency Particulate Air filter screens,” FDA said.

An additional two repeat inspectional citations from October 2017 relate to inadequate training of employees, according to the 483.

Correction: A previous iteration of this article indicated the Form 483 noted eight repeat observations and we regret the error. This article was updated 12 December to reflect the accurate number of repeat observations. 

Hospira Inc. A Pfizer Company FDA Form 483


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