1Contamination control
Non-microbial contamination was observed in your production area.
Inspection Record
Avenue Pharmacy Inc. dba Pathway Pharmacy — FDA 483 Findings
Inspectors Jessica L. PressleyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Your firm produced drugs while construction is underway in an adjacent area without adequate controls to prevent contamination of the production environment and product.
3Other 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.
About this record
Extracted automatically from the document US FDA published on 2020-01-16. 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.
