FDA Inspection Remediation

REGULATORY AUDIT REMEDIATION

Has your organization received a FDA Warning Letter, or threatening to place your organization under a Consent Decree? If you are in a challenging position with the FDA, we are here to help. Effectively responding to these regulatory deficiencies requires cohesive planning and thorough documentation. Synergy Bioscience can help you assemble a complete FDA response package. Out auditors and consultants have comprehensive experience with the processes and procedures related to compliance with the US FDA regulations, as well as Canadian, European, British, Australian, Japanese, and ISO requirements. Experienced professionals at Synergy Bioscience will partner with you to help revamp and resolve deficiencies in your Quality System. These experts are capable of providing pre‐inspection audits for all functional areas and can assist with the remediation of formal inspection findings such as FDA 483, warning letter, consent decree, application integrity policy (AIP), and notified body review report.

Synergy Bioscience has tremendous experience with developing and updating quality systems to ensure compliance will the regulatory requirements, and have managed and executed all levels of remediation activities (Consent Decrees/Warning Letters/Form 483).

OUR SERVICE OFFERINGS INCLUDE:

  • Analyzing the findings of the warning letter or the Consent Decree.
  • Gathering supporting documentation to file with the response
  • Creating a timeline that meets agency expectations
  • Answering any of your questions or questions from the FDA
  • Developing the compliant course of action that will ensure putting your business back to compliance and sustainable growth.

Unlike cookie cutter solutions that other consulting companies usually offer, Synergy Bioscience will help you develop and implement the sustainable compliant approach that will fit your business needs.

CASE STUDY #1

INITIAL SITUATION 

A global life punapharmacy.com sciences industry leader was under a corporate-level warning letter from the FDA, which prevented any new product approvals.

CLIENT OBJECTIVE 
The primary objective was to expedite clearance of the warning letter.

Synergy Bioscience ENGAGEMENT 
Synergy Bioscience deployed and managed cross-functional teams of five to 30 people at client locations across the country to address the warning letter issues. The teams of Synergy Bioscience experts performed the following:

  • Developed action plans and provided monitoring tools to track progress against the remediation plans
  • Performed risk assessments for various products and processes
  • Developed process validations (including IQ/OQ/PQ/PV protocols)
  • Reviewed and updated complaint-handling processes and procedures
  • Coordinated client staff for system remediation
  • Developed processes for integration of post‐market surveillance data into risk assessments and clinical benefit/ risk profiles
  • Updated the CAPA program for correction of deficiencies found in the audit and during remediation

RESULTS 
The FDA removed the warning letter status when the remediation plans had been developed and execution was progressing on schedule across the organization. The client relied on Synergy Bioscience resources to assist with managing and executing this large remediation effort. The client’s internal resources could not have completed the remediation without the Synergy Bioscience assistance, because of the expertise and sheer volume of work required to accomplish the activities in the allotted time.

Ultimately, because of the knowledge transfer and training provided by Synergy Bioscience SMEs throughout the project, this client is now able to sustain regulatory compliance internally, and hasn’t received any further warning letters from the FDA.

CASE STUDY #2

INITIAL SITUATION 
A manufacturer was issued a consent decree by the FDA.

CLIENT OBJECTIVE 
The primary objective was to remediate the quality system issues that prompted the consent decree injunction. Successful remediation would bring the Client back into compliance with FDA regulations.

Synergy Bioscience ENGAGEMENT 
Synergy Bioscience was an integral contributor to the remediation of the issues that prompted a consent decree of permanent injunction from the FDA. Synergy Bioscience key contributions included:

  • Performed gap analysis of objective evidence documentation required to support existing processes and products
  • Developed remediation documentation for FDA Audit Master File Submission
  • Executed Process validation studies
  • Updated Engineering product design control studies
  • Analyzed and optimized design of experiment studies
  • Developed and executed Protocols
  • Wrote and reviewed Protocol summary reports
  • Tested and completed method validation documentation

In addition, Synergy Bioscience SMEs improved the Management of the Quality System functions for the following:

  • Adverse-event reporting
  • Change management system
  • Complaint-handling
  • Internal audit program
  • Supplier audit program
  • Nonconformance control and reporting
  • Corrective and preventive actions (CAPA)
  • Design history files (DHF)
  • Design Control studies
  • Field-actions reporting
  • Process failure mode and effect analyses (PFMEAs)
  • Process verification and qualification
  • Quality data trending studies and reporting
  • Reports of design transfer between medical device manufacturing sites
  • Standard Operating Procedures
  • System design requirement specifications
  • Test methods validations

RESULTS 
The quality system was successfully re-mediated and the terms of the consent decree were met. Synergy Bioscience consultants were recognized for their accountability and accomplishments as part of this client effort, and Synergy Bioscience was contracted for additional activities after the completion of the original scope.

CASE STUDY #3

INITIAL SITUATION 
The FDA had invoked the application integrity policy (AIP) for a pharmaceutical manufacturer. This deferred FDA review of all of the manufacturer’s pending applications.

CLIENT OBJECTIVE 
The primary objective was to remove the underlying reason for the AIP; by developing systems for the organization that will reduce or eliminate the possibility of falsification and increase the focus on the integrity of data and information. The secondary objective was to provide the FDA with documentation that would prompt the agency to revoke the AIC.

Synergy Bioscience ENGAGEMENT 
Synergy Bioscience team developed control systems to increase compliance and reliability, and to reduce or eliminate falsification of data. An important part of this was the development of testing methods, documentation, and data storage that supported compliance.

The team developed systems, including SOPs, templates, forms, and training for:

  • Good Documentation Practices
  • Validation and qualification
  • Analytical testing methods
  • Material-handling
  • Purchasing
  • Data management

Synergy Bioscience provided expert advice on revision of investigation procedures (CAPA and NCR) to ensure accurate root‐cause analysis. In addition, Synergy Bioscience developed and delivered extensive training in all of the topics above, as well as:

  • Good manufacturing practices
  • OSHA laboratory safety procedures
  • Handling blood‐borne pathogens

Synergy Bioscience team also:

    • Created a controlled database of purchasing and inventory systems for all laboratory supplies and primary standards
    • Developed and executed qualifications (IQ/OQ/PQ) for new equipment and applications
    • Supported compliant, reliable data capture during execution of test protocols by developing electronic data systems and testing documentation (canned data sheets) for all:

o Raw materials
o In‐process products
o Finished products

RESULTS 
Upon completion of the remediation project, the FDA revoked the AIP, and resumed substantive scientific review of the Client’s applications.

CASE STUDY #4

INITIAL SITUATION

A major 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 and Warning Letters were inadequate.

CLIENT OBJECTIVE 
Synergy Bioscience was contracted to provide expertise and project management to address the Warning Letter citations. This critical situation required a heightened sense of urgency to ensure timely completion without sacrificing the thoroughness and integrity of the remediation.

Synergy Bioscience ENGAGEMENT 
Synergy Bioscience provided a team of regulatory specialists who led remediation teams in the following areas:

  • Process Mapping
  • CAPA Leadership and Training
  • Complaint Handling
  • Procedure Audits/Reviews
  • Data Trending Methods & Analysis
  • Independent Design History Files Reviews
  • Medical Device Reporting (MDR) process update

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.

RESULTS 
Updated corrective and preventive action (CAPA) program, and nonconformance data trending methodologies were implemented and comprehensive documentation providing objective evidence of effective remediation was prepared. The extensive coaching by Synergy Bioscience consultants over several months was the 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.

To discuss how Synergy Bioscience can help you, please contact us.

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