1Other quality system
Your firm has released product without the documentation of a robust process that yields a high degree of a ssurance in the performance of the manufacturing process.
Inspection Record
Hospira Boulder, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Your quality control unit lacks the responsibility for approving or rejecting all laboratory procedures impacting the identity, strength, quality, and purity of the drug product.
3Other quality system
There is no documentation of the thorough review of failures to meet specifications impacting the identity, strength, quality, and purity of the drug products.
4Complaint and recall handling
A Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
5Equipment and facility
Written procedures are not established for the cleaning of equipment, including utensils used in the manufacture, processing, packing or holding of a drug product.
6Material and supplier control
Materials are not stored in a manner to prevent degradation, contamination and cross-contamination.
7Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
