You produced beta-lactam drugs without providing adequate containment, segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
Inspection Record
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy — FDA 483 Findings
Inspectors Christopher R CzajkaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
You produced hazardous drugs without providing adequate containment and cleaning of utensils to prevent cross-contamination.
Personnel did not change gloves frequently enough to prevent contamination.
About this record
Extracted automatically from the document US FDA published on 2022-04-15. 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.
