1Other quality system
The acceptance status ofproduct was not clearly identified throughout installation and servicing ofthe product.
Inspection Record
Boston Scientifc Corporation — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Not all ofthe actions needed to correct and prevent the recurrence ofnonconforming product and other quality problems have been identified.
3Other quality system
A process whose results cannot be fully verified by subsequent inspection and test has not beenadequately validated and approved according to established procedures.
4Deviation, CAPA, and investigation
A validated process was not revalidated when changes or process deviations occurred.
5Other quality system
Procedures that describe the review and disposition process for nonconforming product were not implemented.
6Other quality system
The organization structureis not adequateto assure that quality system requirements are fully met.
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.
