Hospira, Inc. – FDA 483, Jul 26, 2012

This FDA Form 483 document outlines observations made during an inspection of a drug product manufacturing facility. The inspection revealed several deficiencies related to quality control and manufacturing processes.

Firstly, the written stability program for drug products lacks meaningful test methods. Stability studies and their results are not adequately evaluated for suitability, and the results are not consistently used to establish appropriate storage conditions for finished products.

Secondly, control procedures are not established to monitor the output and validate the performance of manufacturing processes that may cause variability in in-process material and drug product characteristics. Specifically, the process validation for Propofol manufacturing is not adequately designed.

Thirdly, there are no written procedures for production and process controls to assure drug product identity, strength, quality, and purity. The firm has not sufficiently qualified its manufacturing equipment.

Finally, laboratory controls do not include scientifically sound and appropriate sampling plans to assure drug product conformity to standards. Samples for sterility testing are not necessarily representative of each lot. These observations indicate significant issues with the facility's quality system and manufacturing practices, potentially impacting the quality and purity of drug products.