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FDA 483 Warning Letter Remediation
Background
A Fortune 500 company received a FDA 483 warning letter from the FDA, reporting their findings of device adulteration and misbranding, and threatening seizure, injunction, and / or civil money penalties.
This action followed a determination by the FDA that the responses of the firm to certain observations noted on an FDA 483 were inadequate. It was clear a Warning Letter remediation strategy was missing.
Challenge
Regulatory Compliance Associates® Inc. was contracted to provide leadership, expertise, and project management to address the Warning Letter remediation. This critical situation required a heightened sense of urgency to ensure timely completion without sacrificing the thoroughness and integrity of the remediation.
Approach
RCA provided a team of regulatory specialists who led remediation teams in the following areas:
- Process Mapping
- CAPA Leadership
- Formal Problem Solving
- Complaint Handling
- Procedure Audits/Reviews
- Data Trending Methods & Analysis
- Independent Design Reviews
- Medical Device Reporting (MDR)
Warning Letter remediation included gap analyses, development, implementation and training of new or improved procedures, and comprehensive documentation in preparation for a follow-up audit from the FDA.
Result
Formal problem solving, corrective and preventive action (CAPA), and nonconformance data trending methods were implemented, and comprehensive documentation providing objective evidence of effective remediation was prepared. Extensive RCA leadership and coaching over several months were key in transitioning the client culture to ensure that improvements would be sustainable. The subsequent FDA audit following the Warning Letter resulted in zero 483 observations.
About RCA’s Compliance Services
Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates® Inc. can help. Our subject matter experts are internationally known in the regulatory compliance consulting industry.
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA® Inc., we offer the pharmaceutical consultants and resources necessary to guide you in regulatory compliance.
We’re In Compliance
From family-owned enterprises to multinational Fortune 100 companies, we work with all types of pharmaceutical businesses. RCA® Inc. is a certified ISO 9001 organization: we understand navigating the changing demands of the FDA and other regulatory agencies.
Over 500 industry experts, FDA veterans and consulting professionals oversee our services to ensure that your business is protected to the fullest possible extent. Regulatory policy is what we do – and we do more of it than anyone we know.
Assessments
The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our FDA compliance consulting experts have decades of experience in both regulatory compliance program strategy and execution. We’ll help you measure your quality system with FDA regulations to assess any process weaknesses and opportunity to improve.
Our range of compliance regulatory services include:
- cGMP
- Quality Infrastructure
- PAI, Validation
- Facilities and Maintenance
- Laboratory (GLP)
- Process Assessments to Streamline and Optimize New and Existing Systems.
Audits
Periodic regulatory audits are necessary to both ensure the continued quality regulatory compliance of your organization. An internal audit helps maintain your readiness for an FDA inspection — and we have the resources to help. Our experienced team of ASQ-CQA and RABQSA certified auditors is available to perform a range of internal audit services, including:
- Supplier
- API
- Contact Manufactures (CMO)
- Internal
- Quality Systems
- Baseline
- Verification
- Clinical (CRO) and Clinical Manufacturing
- Data Integrity
- 503A & 503B
- Combination Products
Regulatory Agency Response
Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. We can assist you in developing a customized response and plan of action to help remediate the effects of a FDA 483 warning. Our compliance and regulatory services team is here to provide the guidance you need most during this time, with response solutions for:
- FDA Form 483
- Warning Letter
- Consent Decree
- Import Bans
Preparation, Training, and Inspection Readiness
Sitting back and hoping for your next FDA inspection to go well isn’t an option — you need active preparation and training tailored to your needs and business goals. RCA® Inc. will help you thoroughly prepare for inspections with an extensive range of training programs, mock inspections and other readiness solutions, such as:
- Mock Inspections
- Back Room/ Front Room set-up and process
- Inspection Analysis & Report
- Response Letter Assistance
- Proof Book Development
- Business Relations (Leadership Development Training)
- Corporate Regulation Examples
- Regulatory Law
- Regulatory Board
- Legal Compliance
- Corporate Regulation Examples
- Industry Relations (Leadership Development Training)
- Types of Regulation
- Medical Regulations
- Security Regulations
- Cybersecurity Regulations
- Data Compliance Regulations
- Types of Regulation
About RCA
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
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