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US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP ComplianceEnsure equipment calibration and maintenance are conducted regularly and implement risk-based validation protocols aligned with FDA expectations. 4. Train employees on GMP guidelines, CAPA ...
These companies must pass FDA compliance inspections (audits) to 21 CFR 820. One of the key components of these device CGMPs is addressing post-market use issues and complaints/CAPA. The FDA ...
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