1Other quality system
Procedures for acceptance ofin-process product have not been adequately established.
Inspection Record
GPC Medical Limited — FDA 483 Findings
Inspectors Stephen D. EichThe 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
Procedures for Corrective and Preventive Action have not been adequately established.
3Laboratory and QC controls
Process Control] Procedures that describe any process controls necessary to ensure conformance to the specifications have not been adequately established.
4Other quality system
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated.
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.
