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

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

In this episode of ÐÓ°ÉÂÛ̳ 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 ÐÓ°ÉÂÛ̳ Radio, host Brandon Miller and Steve Lynn, who is ÐÓ°ÉÂÛ̳® Inc. (ÐÓ°ÉÂÛ̳) 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...