USDM’s regulatory compliance guidance can help your organization with agency response, remediation, and preventative change management.

USDM has helped correct and prevent hundreds of regulatory agency risks and no remediation effort is ever the same. USDM can identify areas of concern or address an existing concern that needs immediate attention. We have the knowledge and experience to guide you in organizational change management (OCM), resolving issues with processes and procedures, and addressing gaps in your compliance and resources. 

Remediation Support for Life Sciences Companies

Our experts remediate for medical device and other life sciences companies found in violation of:

  • 21 CFR Part 11     
  • 21 CFR Part 210/211          
  • 21 CFR Part 820     
  • EU MDR     
  • EU GMP Annex 11
  • ISO 9000          
  • Quality System Regulation (QSR)     
  • Unique Device Identification (UDI)
  • And many other global regulations

Non-Compliance Remediation Service 

USDM ensures that your processes and procedures are in compliance with global regulations and industry best practices. Examples of our remediation work include:

  • Correct and update medical device design controls
  • Medical Device Remediation
  • Review and update standard operating procedures (SOPs)  
  • Provide SOP training and organizational change management
  • Provide GAMP training
  • Enhance process weaknesses to make more robust
  • Remedy QMS inadequacies
  • Ensure CSV is adequately tested for the intended use
  • Improve manufacturing process failure
  • Solve data integrity issues

Whether you’re a pharmaceutical manufacturer, medical device manufacturer, biotech company, biologics developer, CRO, or in another government-regulated industry, if you’ve been notified by a governing agency, we can help you with your compliance needs.

Government Agency Remediation for Life Sciences

At USDM, we have perfected our approach to remediation. These are some of the steps we take to resolve your compliance issues:

  • Analyze observations and findings and discuss them with key stakeholders and SMEs
  • Develop an action plan to correct and prevent future issues, prioritize actions, and set a timeline
  • Define critical results and metrics to measure success against the action plan 
  • Execute the plan, track progress to critical metrics, and deliver change management and training
  • Share ongoing reporting with the customer to ensure alignment, accountability, and progress

If you have an observation or a potential problem, USDM can assist in a resolution before it becomes a bigger issue; being proactive is more cost effective than having an agency require a fix. Whatever your remediation need – internal observation, 482 notice of inspection, form 483 from the FDA, warning letter received, or Consent Decree issued – contact USDM. We also help with general clinical regulatory consulting and medical device clinical consulting.

Remediation FAQ

  • What do I do after receiving an FDA Form 483 observation or warning letter?

    These reported observations must be taken seriously and promptly addressed. Your organization is required to construct a response letter detailing a timeline and intended course of action to amend the deficiencies uncovered by the investigator.

  • How long do I have to address an FDA Form 483 observation or warning letter?

    Your company has 15 business days from the formal date of issuance to respond to the 483. The FDA need not confirm your response, but you can contact the agency and confirm receipt. Depending on the severity of the issue, the FDA may return for another inspection. If the timeline has not been met or deficiencies not remediated, another 483 will be issued. In fact, the majority of Form 483 issuances are followed by another 483—this cycle could continue for months, even years. 

  • What are the types of FDA Inspections?

    The FDA performs four different types of inspections across many different types of sites. USDM can help prepare you for any of these inspections.

    1. Pre-Approval Inspections (PAI)
    2. Routine Inspections
    3. Compliance Follow-Up Inspections
    4. "For Cause" Inspections

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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