Resources

In this episode of RCA Radio, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates® (RCA) to cover the Medical Device quality standard...

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...

In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel, Matt a board-certified toxicologist with a Ph.D. in chemistry and is...

In this episode of RCA Radio, host Brandon Miller and Steve Lynn, who is Regulatory Compliance Associates® Inc. (RCA) Executive VP of Pharmaceuticals, explore what is happening in the Pharmaceutical...

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...