1Contamination control
Non-microbial contamination was observed in your production area.
Inspection Record
Heartland Home Infusions, Inc., dba HHI Infusion Services — FDA 483 Findings
Inspectors Christina A. Millet'The inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Environmental monitoring
Sporicidal agents are not used in your facility's cleanrooms and/or ISO 5 area.
3Contamination control
Beta-lactam drugs were produced without providing adequate containment, segregation, and cleaning of work surfaces and personnel to prevent cross-contamination.
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.
