The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to ...

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 ...

The FDA criticized Hologic’s corrective and preventive action procedures, citing delayed responses to recurring adverse events such as infections, tissue damage, and device migration.

In this interview, we explore the key changes shaping the pharmaceutical industry, maintaining compliance across global ...

In the fast-paced manufacturing industry, continuous improvement and process optimization are indispensable strategies for ...

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...

Ensure calibration and maintenance of equipment are conducted regularly and implement risk-based validation protocols aligned with FDA expectations. 4. Train employees on GMP guidelines ...

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in breast tissue.