Background
A Fortune 500 company received a 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.
RCA leadership and coaching over several months was key.
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
Regulatory Compliance Associates® (RCA) provides worldwide 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-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
References
- U.S. Food and Drug Administration, Federal Food, Drug, and Cosmetic Act, Chapter V, Sections 501 and 502.
- FDA Code of Federal Regulations, Title 21, Parts 803, 806, and 820. April 1, 2010.
Background
A Fortune 500 company received a 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.
RCA leadership and coaching over several months was key.
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
Regulatory Compliance Associates® (RCA) provides worldwide 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-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
