1Contamination control
You produced hazardous diugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
Inspection Record
White House Pharmacy Inc. dba San Jose Compounding Pharmacy — FDA 483 Findings
Inspectors Kristin M AbaonzaThe 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 beta-lactam mugs without providing adequate containment, segregation, cleaning ofwork surfaces, cleaning of utensils and cleaning ofpersonnel to prevent cross-contamination .
3Contamination control
You produced highly potent diugs without providing adequate containment, segregation, cleaning ofwork surfaces, cleaning ofutensils and cleaning ofpersonnel to prevent cross-contamination.
4Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
