1Documentation and records
The written MDR procedure does not include documentation and recordkeeping requirements for all information that was evaluated to determine if an event was reportable.
Inspection Record
Diagast — FDA 483 Findings
Inspectors Creighton T Tuzon · Richard T Riggie · Elias N Paz AlonzoThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
Procedures for the control of storage areas and stock rooms have not been adequately established.
3Deviation, CAPA, and investigation
Failure to submit a biological deviation report.
4Regulatory reporting and change control
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
5Other quality system
In-process inspections, tests, or other verification activities and approvals were not documented.
6Other quality system
Risk analysis is inadequate and is incomplete.
About this record
Extracted automatically from the document US FDA published on 2026-10-19. 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.
