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# 10 Observations in Hospira FDA-483
- URL: https://www.fdaweb.com/10-observations-in-hospira-fda-483-2/
- Published: 2021-05-25T12:00:00.000Z
- Updated: 2026-09-14T17:00:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149402

FDA has released the FDA-483 issued following a 12/9/19-1/17/20 inspection at the Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations on the [form](https://www.fda.gov/media/148857/download?ref=fdaweb.com) were: 

- failing to fully follow the responsibilities and procedures applicable to the quality control unit;
- failing to establish control procedures that monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and drug product;
- failing to have adequate exhaust systems or other systems to control contaminants in areas where air contamination occurs during production;
- failing to follow written production and process control procedures in the execution of production and process control functions;
- failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
- procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the aseptic and sterilization process;
- written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up;
- acceptance criteria for the sampling and testing conducted by the quality control unit are not adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release;
- master production and control records lack complete manufacturing and control instructions and precautions to be followed; and
- failing of the firm’s examination and testing of samples to assure that the drug product and in-process material conformed to specifications.