Resources

A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. RCA suggested a CBE 30, which they submitted to the FDA, addressing product complaints and maintaining...

RCA was contracted to perform a gap assessment of eight quality software systems and 29 laboratory software systems. After reviewing remediation plans, the FDA chose not to make a regulatory...

In this episode of RCA Radio, host Brandon Miller, Steve Lynn, Regulatory Compliance Associates Inc.'s (RCA) Executive VP of Pharmaceuticals, and Walter Mason, RCA's Sr. Director of Quality Control and...

In this episode of RCA Radio, host Brandon Miller and Steve Lynn, who is Regulatory Compliance Associates (RCA) Executive VP of Pharmaceuticals, provide an outlook into the most important things...

Background A mid-sized company received a 10-item FDA Form 483 and submitted an initial response. However, the response was followed by the issuance of a Warning Letter, leaving the company...

A leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document change process.