10-3 - REGULATORY MEETINGS

A Regulatory Meeting is a meeting requested by FDA management at its discretion, to inform responsible individuals or firms about how one or more products, practices, processes, or other activities are considered to be in violation of the law. FDA is not required to hold a Regulatory Meeting and, except for a few specifically defined areas (see RPM Chapter 4 – Warning Letter Procedures), is not required to provide any other form of prior notice prior to taking an enforcement action (see RPM Chapter 10).

Regulatory Meetings can be an effective enforcement tool to obtain prompt voluntary compliance, and have been used successfully in a variety of different situations, including:

1. As a follow-up to a Warning Letter when firms have corrected the majority of violative conditions noted in the Warning Letter, to provide additional encouragement, direction, and assistance in achieving compliance. As a follow-up to a Warning Letter, FDA officials may remind a firm or individual in a Regulatory Meeting that failure to make appropriate corrections in a timely manner may result in enforcement action.
2. To communicate documented violations that do not warrant the issuance of a Warning Letter. Under these circumstances, a Regulatory Meeting provides the added benefit of real time, two-way discussion of the violations and the appropriate corrective actions.

A Regulatory Meeting should not be used as a substitute for an Untitled Letter when a particular compliance program calls for the issuance of an Untitled Letter. Also, in most cases, a Regulatory Meeting should not be used to initially communicate violations of regulatory significance. Such violations are generally best communicated in the form of a Warning Letter.  However, there are some situations when a regulatory meeting may be used to initially communicate violations of regulatory significance. Examples include:

1. When a Regulatory Meeting is held to communicate a health hazard and the necessity for immediate corrective action to address violative product that is on the market.
2. When a Regulatory Meeting is held in conjunction with the issuance of a Warning Letter to emphasize the significance of the violations.

A successful outcome of a Regulatory Meeting would include a commitment by the responsible individuals to correct the conditions or practices at their facility that are in violation of the law. The districts, at their discretion, would typically verify these commitments through evaluation of subsequent communication and documentation and/or a follow-up inspection. The inspection classification should reflect the significance of the violations and can be appropriately modified based on the adequacy of the corrective action. In those instances where the corrective actions are not satisfactorily carried out, definitive plans should be made for follow up action by the District. Consult with the involved Center and OE is advisable.

Any FDA organization with regulatory oversight of a firm or individual has the discretion to decide whether or not to hold a Regulatory Meeting. If a Center decides to hold a Regulatory Meeting concerning observations made by one or more Districts, the Center should invite any districts involved and consider any objections that such district(s) may have to such meeting.  Centers are also encouraged to invite district participation in Regulatory Meetings concerning observations or matters originating in the Center (e.g., unapproved new drug or device issues). Any disagreement between a Center and a District about whether to conduct a Regulatory Meeting should be resolved by collaborative discussion with the Center, District, and OE.

For situations that involve corporate-wide violations or multiple districts, the meeting should include the affected Centers, OE, and the involved Districts. The location of the meeting should be negotiated by the involved parties.

Summary minutes must be prepared for all regulatory meetings.