Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again

BioProcess Online | Guest Column | September 12, 2019 | By Judy Carmody, Ph.D., Carmody Quality Solutions, LLC

Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.

News about the company Immunomedics, which had a number of issues cited in an FDA Complete Response Letter (CRL) and Form 483, drove this point home recently. The news involved the FDA citing Immunomedics in January 2019 for data manipulation and breaches during an August 2018 inspection. Read full article.