FDA Update – September 6, 2023

Post-Warning Letter Meetings with FDA – Guidance for Industry

The U.S. Food and Drug Administration (FDA) has recently released a guidance document that directly affects our industry: Post-Warning Letter Meetings With FDA – Guidance for Industry.

The guidance provides information on the implementation of the post-warning letter meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA).

Navigating the Post-Warning Letter Process:

This guidance document outlines the process for eligible facilities to request a post-warning letter meeting with the FDA. Such meetings are crucial for addressing ongoing remediation efforts related to Current Good Manufacturing Practice (CGMP) deficiencies highlighted in a warning letter. Here are key elements from the document:

1.Requesting a Meeting:

• Eligible facilities, upon receiving a warning letter, have the opportunity to request a post-warning letter meeting with the FDA.
• The request should be submitted within 15 calendar days of receiving the warning letter.
• The FDA outlines the necessary information to include in the meeting request, ensuring clarity and effectiveness in addressing CGMP deficiencies.

2. Preparing and Submitting a Complete Meeting Package:

• The guidance document details the components of a complete meeting package. This includes a comprehensive remediation plan that outlines specific actions and timelines for addressing CGMP deficiencies.
• Facilities are encouraged to submit the meeting package electronically to facilitate efficient review by the FDA.

3. FDA’s Approach to Post-Warning Letter Meetings:

• The FDA is committed to working collaboratively with facilities to ensure the remediation process is well-understood and successful.
• The document explains the FDA’s intent to conduct a meeting that is open, transparent, and conducive to addressing CGMP issues effectively.
• The agency outlines its expectations for facilities’ preparedness and participation in these meetings, emphasizing the need for a constructive dialogue.

4. Demonstrating Commitment to Compliance and Quality:

• Post-warning letter meetings present an opportunity for facilities to showcase their dedication to compliance and product quality.
• By proactively addressing CGMP deficiencies, we reinforce our commitment to delivering safe and effective products to our customers.

In summary, this guidance document provides a clear pathway for facilities to engage with the FDA in addressing CGMP deficiencies highlighted in a warning letter.   It underscores the importance of timely communication, thorough remediation plans, and collaborative efforts to ensure compliance and uphold the highest standards of quality.

mdi has been providing FDA regulatory consulting services on cGMP compliance since 1978. We have always worked closely with the FDA on 483 responses as well as Warning Letter mediations. Though the FDA has come out with this guidance document, the FDA was always open to both pre-warning letter meetings and post-warning letter meetings. Before you have such a meeting, you should be aware of what the FDA is expecting with your corrective actions as a result of the inspection. One of the reason you may get a warning letter in the first place is because your corrective actions proposed in the 483 response were not adequate.Therefore, it is critically important to contain the situation at the 483 level by providing a comprehensive response that can satisfy the FDA. mdi has specialized in reviewing the 483 and preparing an appropriate response to the 483 with the intention of preventing the issuance of the Warning Letter.

We are dedicated to navigating this process diligently, underscoring our unwavering commitment to you, our valued clients. As always, your trust in mdi Consultants drives us to continually improve and deliver excellence in every aspect of our operations.

Should you be in a violative FDA inspection and/or have a 483 and need assistance in preparing the response to the observations, please contact mdi immediately. If you have any questions or require further information, please do not hesitate to reach out to us. Your success and satisfaction remain at the forefront of our endeavors.

For the original update, please visit the FDA’s website.

For any further questions regarding your companies Quality System, as well as assistance with requesting a meeting with the FDA regarding a warning letter, please email mdi Consultants at [email protected] RE: Post-Warning Letter.