1Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
Inspection Record
Rx Unlimited Pharmacy — FDA 483 Findings
Inspectors Jolanna A Norton · Gunneet KaurThe 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
Vennin was observed in an area immediately adjacent to your production area.
3Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
4Contamination control
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
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.
