Resources

Client Challenge A global pharmaceutical and medical device company faced challenges in scaling its workforce to meet the demands of rapid business growth and increasing regulatory oversight. Specifically, the company...

A pharmaceutical company engaged RCA to prepare the company for an FDA Audit. The company implemented the recommended changes and passed the inspection.

RCA was contracted to develop validation documentation and provide validation services to ensure software was adequately validated and the valve assembly machine was prepared for production.

A global health care company received an FDA Warning Letter for quality issues with its manufacturing facility. RCA crafted and implemented an improvement plan, which improved quality, compliance, and financial...

A large global medical device manufacturer received a Warning Letter from the FDA as a result of repeat 483 observations for process validation deficiencies.

Background A medical device manufacturer was encountering recurring instances of unacceptable endotoxin levels on finished, cleaned surgical needles. The issue led to an FDA 483 observation citing non conformances with...