When the FDA issues a company an Untitled Letter, 483, Warning Letter, or a Consent Decree, responding to the FDA is time-critical. Compliance Gurus team of experts can quickly review your FDA findings and work closely with your organization to create a timely response along with a FDA compliant remediation plan.
If your FDA citation is for a lack of compliance with Data Integrity, CSV, and 21 CFR Part 11, our experts can assess your company’s current state while identifying any gaps in compliance. Subsequently, we can create your FDA remediation plan as well as assist your company with implementing your FDA remediation plan that will ultimately bring your organization back into a FDA compliant state.
