Program & Project Management

FDA Warning Letter & 483 Remediation

Alleviate the difficulties of remediation and successfully reach compliance by utilizing our team’s vetted knowledge in creating effective strategies to resolve complex regulation nonconformance issues

Resolving agency deficiencies and remediating FDA warning letters can be overwhelming and complicated undertakings. Firms must rapidly implement effective interim controls while maintaining the efficiency of their processes to avoid creating new bottlenecks, and inevitably, more deficiencies. In addition, long term solutions that successfully balance quality improvement and resource allocation must be implemented to ensure the prevention of deficiencies overtime. Adding more control steps without proper risk assessment is easy but implementing quality remediation steps that last in the long run is hard.

Overview

Address FDA warning letters and 483 remediations with Concuir’s team of experts in resolving complex regulatory and quality issues to guide your organization to a state of compliance. Take advantage of our in-depth knowledge on quality management to reinforce your organization by working synergistically and compliantly.

An effective quality system means one step closer to a successfully managed operation and assists in generating high quality products.

Quality Management Strategies via...

Improved master remediation schedule through detail expansion

Continual Improvement

Proper resource allocation

Change Management

Company-wide goal alignment through communication strategies

Portfolio development and management

Quality Planning

Project Examples


FDA 483 Form Remediation

Our client was issued an FDA 483 Form and tasked our team with the challenge to rectify and reform their current company practices.

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