Inspection Insights

Clopidogrel oral liquids recall: assay control, OOS investigation and batch impact assessment

Inspection Insights top-pharma -
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 recall covering all strengths and all batches of Xeal Pharma’s...

FDA inspections: who will inspect your site — and who decides the outcome?

Inspection Insights top-pharma -
An FDA inspection involves more than the investigators who visit a manufacturing site. The reason for the inspection, the field team's findings and the...
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