1Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
Inspection Record
Mooney's Pharmacy Inc. — FDA 483 Findings
Inspectors Brandon C. HeitmeierThe 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
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning ofwork surfaces, utensils, and/or personnel to prevent cross-contamination.
3Other quality system
The production areas have difficult to clean, particle-generating, and visibly dirty surfaces.
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.
