This past August, FDA issued a warning letter to Soleetech Corp., a Taipei, Taiwan-based manufacturer of airway connectors. The agency was not impressed with this organization’s level of compliance.

Over years of working with medical device companies, we’ve found that there is a particular area that is often rife with issues for companies — CAPA (Corrective Action and Preventive Action). We see a ...

Establishing a corrective and preventive action (CAPA) system is a quality system regulation (QSR) requirement for medical device firms marketing products in the United States. Although FDA has always ...

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe ...