1Material and supplier control
Lack of adequate written procedures for obtaining a homogeneous raw material sampling.
Inspection Record
Hospira Boulder, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment 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.
3Other quality system
The firm did not follow their Standard Operating Procedures.
4Other quality system
The firm has released product without the documentation of a robust process that yields a high degree of assurance in the performance of the manufacturing process.
5Other quality system
Detailed manual vessel scrub procedures and locations.
6Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
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.
