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# Pfizer Hospira Unit Hit with Yet Another FDA-483
- URL: https://www.fdaweb.com/pfizer-hospira-unit-hit-with-yet-another-fda-483/
- Published: 2018-12-10T12:00:00.000Z
- Updated: 2026-09-15T00:49:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142998

Pfizer’s Hospira drug unit appears to be getting deeper into FDA hot water involving intractable GMP issues at the firm’s McPherson, KS sterile drug manufacturing site. The latest indication is a just-released Form FDA-483 that lists numerous repeat observations cited after an August follow-up inspection at the site. A 2016 inspection there led to a significant Warning Letter in 2017 ([see story](https://www.fdaweb.com/cgmp-violations-at-hospira-facility/)). The company responded “adequately” to the Warning Letter’s findings, and FDA issued a [“close out” letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm614613.htm?ref=fdaweb.com) in June, stating that promised corrective actions would be assessed in future FDA inspections.

The 2017 Warning Letter took issue with repeat GMP findings seen at multiple sites, which it said “demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate. Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements.”

The [recent FDA-483](http://recent%20FDA-483) cited eight GMP observations, including seven that were repeat findings from the 2016 or other inspections. For example, the document said Hospira failed to thoroughly review unexplained discrepancies. Additionally, the firm was cited for inadequate procedures for validating its aseptic processes, and for failing to submit timely NDA Field Alert Reports after receiving information that a distributed drug batch did not meet its specifications.