FDA 483 / Warning Letter Remediation

FDA 483 / Warning Letter Remediation, supplier and contract partner audits

How Does it Work?

Receiving an Inspection Report noting observations or a Warning Letter from a regulatory agency is serious, yet often only addresses a small portion of the true deficiencies in the quality system. Successfully constructing a remediation plan, communicating a thorough and timely response to the agency, and then executing the remediation process are all critical to regaining the confidence of regulatory authorities.

MEDVACON can help determine the actual depth and breadth of the quality system deficiencies using a comprehensive FDA Compliance GAP Assessment. The GAP Assessment includes performing baseline audits and developing a remediation plan to address all deficiencies to bring the Quality System or specific sub-section into compliance. For clients already aware of deficiencies, MEDVACON’s staff of compliance experts are at the ready to tackle those specific areas.

Responses must convey a keen understanding of both the issues and contributing factors, as well as communicating a commitment to achievable and measurable improvements. Remediation efforts often fail because either a rigorous evaluation of all root causes has not been performed, or a clear and manageable path to addressing them has not been well defined or executed. MEDVACON can assist in preparing your organization for the follow-up inspection by delivering rigorous and comprehensive remediation services that are designed to provide cost efficient resolutions.

Example Projects:

Warning Letter Remediation - Aseptic Combination Product Manufacturing Client

MEDVACON was employed to assist with the response to an FDA Warning letter received by an aseptic combination product client. MEDVACON assisted in conducting investigations into deviations and non-conformances in the aseptic manufacturing suites to produce the combination product. By deploying a team of experts to conduct investigations and assist this client in meeting stringent FDA commitment timelines MEDVACON resolved a highly technical issue with the combination product mechanical components and successfully identified and implemented complain processes that resolved the issue. The FDA commitment timelines were met, and the team continues to assist this client with ongoing investigations, closeouts, and quality systems consulting services.   

FDA Form 483 Remediation – Contract Packager

MEDVACON was engaged by a contract packaging company that was issued a FDA Form 483 related to cleaning validation.  MEDVACON assigned a Senior Cleaning and Process Validation expert to lead this initiative. MEDVACON drafted the response to the FDA Form 483 and submitted it to the President of the client company.  The response was used in its entirety.  In addition, MEDVACON analyzed the FDA findings and existing cleaning approach and developed a new Cleaning Validation Program that met the client and FDA needs while leveraging as much of the existing cleaning program as possible while introducing new concepts.  These new innovative concepts were instrumental in meeting the needs of a contract packager, where each of their new clients can impact a traditional cleaning validation approach.  In addition to developing the new cleaning validation program, MEDVACON developed the RFP and lead the process to select the appropriate testing laboratory to process the cleaning coupons as well as surface swab samples.  The client is extremely happy with MEDVACON ’s leadership on the initiative. 

Warning Letter Remediation – Pharmaceutical Company

We were engaged by a pharmaceutical client that received a Warning Letter with findings related to the entire quality system.  A team of remediation resources was brought in to develop and implement a new Quality System current with FDA requirements. This new system impacted several areas of the operation including Manufacturing, Packaging, Laboratory, Procurement, Information Technology, to name a few.  Upon approval of the newly developed Master Validation Plan each of the respective areas systems and equipment was assessed against the new standards.  This resulted in dozens of systems requiring new validation and dozens requiring revalidation to new standard.  The remediation team of over seventy consultants remained on task for approximately eighteen months and ultimately was successful in having the Warning Letter lifted.

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