A recent edition of Medical Device Daily featured reporting on yet another medical device manufacturer that received a warning letter from the FDA for serious violations uncovered during an inspection. One of the most serious red-flag findings in the warning cited that the quality system had “never been reviewed for suitability or effectiveness.” The warning also included a citation stating that the company did not have any procedures for medical device reports (MDRs). Sadly, the firm’s managers admitted that they were “unaware of the requirements of” the pertinent portion of the Code of Federal Regulations.
The violations cited in the warning letter spring primarily from this company’s QMS system, or lack thereof – but the story also points out the trouble a company can get into by not even knowing about pertinent regulation requirements. This also pertains to validating a company’s ERP system.
Another source reports that in the first three months of 2012, 35 life sciences companies received warning letters. 23 were sent to medical device companies; 14 of those were cited for corrective and preventive action (CAPA) or quality audit violations, and six for process validation violations.
The sad thing is that these violations and the accompanying consequences could easily have been prevented.
FDA violations can have serious ramifications, including seizure and injunction. Just as important are the losses in reputation, customer relationships and revenue. Across the life sciences industry, billions of dollars of revenue are lost each year due to companies taking a casual approach to FDA regulations.
That’s why a strong compliance program, supported by appropriate software applications, is mission critical for every life sciences company – from start-ups, to emerging companies, to established corporate behemoths.
At Strategic, we are in the business of helping our clients succeed – for our life sciences customers that also means implementing robust FDA compliance measures. While we can’t force a company to take appropriate action, we are very clear with our clients on the appropriate steps needed to comply with FDA regulations.
Strategic provides a full range of life sciences solutions – including ERP, CRM, and QMS – that provide an effective platform for growth and for meeting regulatory and compliance mandates. Just as important, our life sciences customers know they can rely on us as a trusted partner to not only deliver a comprehensive technology solution, but also to help them cover compliance risk.
We’ve got your back – don’t take any chances on becoming an FDA compliance statistic. If you have any questions about validating your QAD ERP, QMS implementation or review, support for GMP or other FDA-related issues, don’t hesitate to contact your Strategic account manager or call us at today at 760-697-1050.
Additional resources: Prepare for CAPA System Scrutiny In Device, Drug and Biologics Inspection; http://www.fdanews.com/prepareforcapa