Corporate Compliance

How should my facility respond to an FDA Form 483?

Compliance Monitor, October 7, 2005

Q: If FDA inspectors file a Form 483 outlining compliance observations and list problems for a clinical trial at my facility, how should I reply to it?

A: Although you are not obligated to do so, you should reply to the 483 within three weeks. The reply should discuss in detail how you intend to address any deficiencies. Ordinarily, if an organization adopts new procedures or provides staff training, it will address the specific problem and reduce the possibility of recurrence. Also, if you can correct an observation after the fact, do so. A reply to the 483 often is sufficient to end a matter. However, the FDA may send follow-up correspondence seeking further clarification.

Your reply to the FDA should address the FDA's concerns. You may also dispute an observation that is not accurate or is not a violation of the FDA's regulations. But don't act defensive, sound argumentative, or raise frivolous or minor objections to the FDA's observations.

The FDA is looking at your reply for several purposes, including the following

  • To see that you understand the FDA's specific regulatory requirements and appreciate the seriousness of the requirements

  • That you are undertaking corrective action to resolve the observation regarding the study audited, if corrective action is appropriate

  • That you have taken corrective action to reduce the possibility that a similar problem will occur in the future

    Your reply to the FDA should be honest and realistic. Replies to a 483 should be sent to the inspector and the FDA district office unless the inspector tells you otherwise.

    Review your clinical trials agreement (CTA) to determine whether you are required to notify the study sponsor about the 483. The sponsor can assist you with your replay to the FDA, although typically neither the FDA nor CTA will require that step. However, even if you take advice from the sponsor, you are personally responsible for the accuracy and completeness of your reply and any corrective action commitments you make to the FDA.

    Determine whether a 483 (for an ongoing study) should be submitted to the IRB based on the IRB's reporting requirements.

    This week's experts are Christie Morgan, CCRC, managing director of clinical research for Newton-Wellesley in Newton, MA; Robert Nicholas, JD, partner at McDermott, Will, & Emery; and Sandra Vose, MBA, head of global monitoring for Covance Inc.'s Late Stage Development Services. Together they wrote Clinical Trials Roadmap for Physician Practices, published in January by HCPro, Inc.

  • Most Popular