1Other quality system
The RDRC did not assure that the investigator utilized adequate instrumentation for the detection and measurement of the specific radionuclide.
Inspection Record
PETNET Solutions Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Your process controls did not include control of in-process materials to ensure that the materials are controlled until required tests or other verification activities have been completed or necessary approvals are received and documented.
3Equipment and facility
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
About this record
Extracted automatically from the document US FDA published on 2026-07-13. 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.
