1Quality unit oversight
Your firm faited to establish adequate quality control unit oversight with the responsibility and authority to approve or reject production and quality documents.
Inspection Record
Hospira, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Failure to establish process controls designed to assure that the drug products manufactured have the identity, strength, quality, and purity that it purports or is represented to possess.
3Equipment and facility
Failure to maintain equipment and facilities in a good state of repair in g drug product manufacture.
4Other quality system
Procedures in @ @ drug product manufacture are deficient.
5Other quality system
Your firm failed to establish adequate controls to ensure documentation is complete, accurate, appropriately reviewed and traceable.
6Equipment and facility
Equipment and facilities ing@ drug product manufacture are not adequately designed or located.
About this record
Extracted automatically from the document US FDA published on 2026-07-10. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
