<h1 class="entry-title">Group: FDA 483 and Warning Letter Resolution</h1>

Quality Assurance Manager – Class II and III device Manufacturer

“…The most immediate benefit of your services is the comprehensive analysis of our company’s quality management system and its level of compliance with FDA and ISO standards. Following the internal audit provided by ComplianceAcuity, the company was aware of where its quality management system was vulnerable and where its resources should be focused…”

Sr. Process & Quality Manager

“…Thanks!  This SOP is much higher quality than what we had in our current QMS… When someone does quality work, I like to let them know about it.  For the SOPs you have sent me, I really like the breadth and depth of what you provided.  It gives me an excellent platform to customize from…”

Director of Quality – Class II & III device Manufacturer

“…Kevin was very diligent and rigorous in his processing work for the CHS/CAPA system. He talked to all those involved to be sure of his facts so that the system was compliant but also reflected the practice, except where we needed to change it. Kevin also responded to “emergency” type issues and changed his schedules […]

12-year veteran in various positions including Director of Quality

“…The systems you delivered are highly customized to meet our compliance requirements and business needs.  All interactions were very professional and goal-oriented. [We] did not have the ‘band-width’ in a couple areas which ComplianceAcuity helped us cover:  1. Compliance and regulatory understanding, was/is not wide-spread.  2.  Having the skill sets and time to create Policies/Procedures/Work […]