Warning Letter/QA Remediation

Warning Letter/QA Remediation

Operating a manufacturing facility under the watchful eye of the FDA is not an easy experience. Assuring that overall quality systems are in place that deal with CAPA, Complaints and a host of other areas are running smoothly totally consumes my team’s capacity. When my company was issued an FDA warning letter it became rapidly clear that this problem would require consulting experts. Enter NovusLife who turned out to be the real difference maker. They sent their top quality representative to us with only a three day notice to develop strategic plans for addressing the warning letter’s substance. I soon realized that Novus could also build out the required resources who understood what to do and how to do apply the strategic plan. All NovusLife team members were top-notch professionals who knew their business and got the job done for us in a timely manner.

- VP of QA, Class 3 Medical Device Company

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