Hospira Healthcare India — FDA 483 Findings

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and 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.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

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.

Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time ofperformance.

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.

An™® Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

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

The calibration of instruments is not done at suitable intervals in accordance with an established written program and with provisions for remedial action in the event accuracy and/or precision limits are not met.

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.