1Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly duty equipment or surfaces.
Inspection Record
East Orange VA Medical Center — FDA 483 Findings
Inspectors Logan T WilliamsThe 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
The sinks are present directly adjacent to the ISO 5 area.
3Contamination control
Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
About this record
Extracted automatically from the document US FDA published on 2025-06-02. 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.
