Hospira, Inc — FDA 483 Findings

Employees engaged in the manufacture and processing of a drug prodoct lack the training required to perform their assigned functions.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Equipment used inthe manufacture, processing, packing or holding ofdrug products is not ofappropriate design to facilitate operations for its intended use.

Buildings used in the manufacturing and processing of a drug product are not mainlailled in a good state of repair.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Rejected in-process materials are not identified and controlled Wlder a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable.

Aseptic processing areas are deficient regarding humidity controls.

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications prior to release.

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

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

Equipment for adequate control over air pressure, hrunidity, and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

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

Procedures designed to prevent microbiological contamination ofdrug products pu:qJorting to be sterile are not established, written, and followed.

Written production and process control procedures are not followed in the execution ofproduction and process control functions.

Procedures designed to prevent microbiological contamination of drug products pwporting to be sterile do not include adequate validation ofthe sterilization process.

Written specifications for laboratory controls do not include a description of the testing procedures used.

Drug product production and control records, are not approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

Laboratozy records do not inc~ude complete data derived from all tests, examinations and assay necessary to assure compliance with establiShed specifications and standards.

There are no wriuen 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.

The responsibilities and procedures applicable to the quaJjty control unit are not in writing and fully followed.