You produced beta-lactam drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
Inspection Record
Arnold Professional Pharmacy — FDA 483 Findings
Inspectors Sena G Dissmeyer · Roseline N Boateng · Natasha GuptaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
Non-microbial contamination was observed in your production area.
You use equipment in production of drug products that have difficult to clean surfaces.
About this record
Extracted automatically from the document US FDA published on 2022-12-15. 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.
