1Contamination control
You produced hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination.
Inspection Record
Curexa - East, LLC dba Curexa — FDA 483 Findings
Inspectors Sena G Dissmeyer · Jessica S EstripletThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
3Contamination control
Non-microbial contamination was observed in your production area.
About this record
Extracted automatically from the document US FDA published on 2022-12-07. 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.
