Hospira Inc — FDA 483 Findings

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.

Acceptance criteria for the sampling and testing conducted by the quality control unit is 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.

There is a failure 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 been already distributed.

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.

Control procedures are not established which 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 the drug product.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.