Hospira Inc. — FDA 483 Findings

Investigations ofan unexplained discrepancy and a failure ofa batch or any of its components to meet any ofits specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.

Procedures for quality audits have not been adequately established.

Deviations from written sampling plans and test procedures are not justified.

Control procedures are not established which validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics ofin-process material and the drug product.

Corrective and preventive action activities and/or results have not been adequately documented.

There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any ofits components to meet any ofits specifications whether or not the batch has been already distributed.

Management with executive responsibility has not reviewed the suitability and effectiveness ofthe quality system with sufficient frequency.

Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design and suitably located to facilitate operations for its intended use and cleaning and maintenance.

Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding ofa drug product.

Written records ofinvestigations into unexplained discrepancies and the failure ofa batch or any ofits components to meet specifications do not always include the conclusions and follow-up.

Process validation activities and results have not been adequately documented.

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

Buildings used in the manufacture, processing, packing, or holding ofa drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.

There is no written testing program designed to assess the stability characteristics of drug products.

Employees are not given training in the particular operations they perform as part oftheir function.

The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.

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

Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.