Every CAPA that reopens six months later had an effectiveness check signed off, never measured. QSIT reviewers cross-reference complaint trends against your own closure dates. A closed ticket is just a timestamp. #MedicalDeviceQMS #ISO13485 #CAPA #FDAInspection #AuditReady #qmsWrapper

#FDARecall triggers an #ImportBan for Indian company due to #SeriousCGMP (Current Good Manufacturing Practice) deficiencies observed during an #FDAInspection.

Maybe the solution is to make clean affordable drugs here in the USA and reduce dependence on imports; especially while the world hates us.

Are you looking to ace your upcoming FDA Pre-Approval Inspection? Our latest article provides expert tips to help you navigate this critical process confidently.

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