1Other 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.
Inspection Record
Professional Arts Pharmacy — FDA 483 Findings
Inspectors Djamila Harouaka · Sena G. Z. DissmeyerThe 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
You produced highly potent or hazardous drugs without providing adequate cleaning of work surfaces and utensils to prevent cross-contamination.
3Material and supplier control
Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.
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.
