Hospira Inc. — FDA 483 Findings

The written stability program for drug products does not include meaningful test methods.

Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

Control procedmes 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.

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

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.