1Training and personnel
You lack personnel with the necessary training and experience to perform their assigned functions.
Inspection Record
Isorx Cyclotron Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
You did not review production records to determine whether errors had occurred.
3Documentation and records
Your batch production record did not include labeling.
4Deviation, CAPA, and investigation
You did not have written production and process control procedures to ensure that any deviations from the procedures are justified.
5Documentation and records
Permitted variations in the amount of component necessary are not reasonable and not specified in the master production and control records.
6Other quality system
You did not establish and follow written quality assurance procedures.
7Material and supplier control
You did not establish written procedures describing the identification of components.
About this record
Extracted automatically from the document US FDA published on 2026-07-10. 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.
