Government regulatory compliance guidance to help your organization with agency response, remediation, and preventative change management.

No remediation effort is ever the same. USDM can help identify if there is an area of concern or address an existing concern that needs immediate attention. We have many years of experience helping our customers develop, enhance, and manage organizational change management to resolve any issues with processes and procedures and build a program and plan to address gaps in compliance and resources needed to correct the problem.

Expert Remediation Support for Medical Device Companies and Life Science Companies:

We help remediate companies who have been found to violate:

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

USDM has helped correct and prevent hundreds of regulatory agency risks.

Non-Compliance Remediation:

Examples of remediation work conducted by USDM to ensure streamlined compliance against global regulations and industry best practices:

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, CROs, or working and manufacturing in another government-regulated industry, if you’ve been notified by a governing agency, we can help you come to compliance.

Government Agency Remediation for Life Sciences:

USDM has perfected our approach to remediation. Below are the steps we take to solve your compliance issues.

Analyze and/or conduct assessment of observations and findings and discuss with key stakeholders and SMEs
Develop an action plan to correct and prevent future issues, prioritize actions, and set timeline
Define critical results and metrics to measure success against the plan
Execute the plan, track progress to critical metrics, 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 help fix it before it becomes a much bigger issue. It’s much cheaper to fix it before an agency requires you to fix it. Wherever you are in your remediation need – internal observation, 482 notice of inspection, form 483 from the FDA, warning letter received, or Consent Decree issued – USDM can help! We also help with general clinical regulatory consulting and medical device clinical consulting.

FAQ

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

You’ve just been issued an FDA Form 483 observation or warning letter following FDA inspection of your operations. These reported observations must be taken seriously and promptly addressed. Following receipt of a 483, 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 will find it prudent to contact the agency and confirm receipt. Depending on the severity of the issue, the FDA may return for another inspection, and if the timeline has not been met or deficiencies not remediated, another 483 will be issued. In fact, 98% 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.
1. Pre-Approval Inspections (PAI)
2. Routine Inspections
3. Compliance Follow-Up Inspections
4. For Cause Inspections
Each response should be customized for the specific process and procedures at the site and USDM can help prepare you for any of these types of inspections.

I don’t have the time or resources to fix my own remediation, what do I do?

Outsourcing your remediation needs is a great way to save time and money. USDM has been helping life sciences companies solve their remediation challenges for 20 years. Please contact us at (888) 231-0816 or usdm@usdm.com.
After remediation, how do I stay compliant?

One of the critical factors to a successful remediation is to ensure the necessary organizational change management processes have been put in place to prevent similar issues in the future. At USDM we don’t simply fix a broken process or procedure, but we build a program and plan to address gaps in compliance and resources needed to correct the problem going forward so that you can prevent similar issues in the future. We also provide the necessary training to ensure employees understand and adopt the new processes and procedures.