Ensure 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 ...

The FDA continues to find fault with investigations and the stated ... and proper determination of root cause and CAPA. Therefore, it is important that investigators conduct each and every ...