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# CGMP Violations at Hospira Facility
- URL: https://www.fdaweb.com/cgmp-violations-at-hospira-facility/
- Published: 2017-02-28T12:00:00.000Z
- Updated: 2026-09-14T22:09:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138078

A 5/10-6/8/16 FDA inspection at Pfizer’s Hospira drug manufacturing facility in McPherson, KS, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/14 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm542587.htm?ref=fdaweb.com) from the agency’s Kansas City District Office. Specific violations included: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- failing to establish valid in-process specifications;
- failing to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to control rejected in-process materials under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable; and
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter also says that Hospira failed to submit field alert reports to FDA and notes that the agency found similar CGMP violations at other facilities in the company’s network. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” it says.

The company was told to correct the violations promptly and to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.