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Why Fear Form-483?

By November 24, 2008

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Form-483 is the Food and Drug Administration (FDA) List of Inspectional Observations form that is used to report compliance issues following an on-site inspection. Depending on your industrial niche, you are required to comply with certain operational regulations. For example, pharmaceutical companies are expected to follow Good Manufacturing Practice (CGMP) regulations and device user facilities must follow the Safe Medical Devices Act (SMDA; 1990) and Medical Device Reporting (MDR) regulations.

The form is meant to be used to report only significant deviations directly related to applicable regulations. Despite this, it may introduce a measure of ambiguity and personal bias on the part of inspectors, as regulations and the definition of significant may be interpreted differently. At the conclusion of an on-site visit to your facility, the FDA investigator will present the Form-483 outlining any issues identified during their inspection. While there may be obvious non-compliance issues that require immediate attention, you may take this opportunity to ask questions and should view it as a chance to learn how to improve your processes. If you still need clarification on the FDA policies, it is suggested that you write to the FDA headquarters (not your local district office) where policy issues are addressed. You shouldn’t be afraid of the Form-483 but think of it as an opportunity to clarify where there might be problems in your operations. I would suggest even incorporating such improvements into your company milestones so they are taken seriously and addressed in a timely fashion. In doing so, you can protect your company by addressing these issues in order to avoid future mishaps.

Sources:

Tourault, M. What is the Significance of FDA Form-483. Citings, March 2002.

Goebel, P., Whalen, M., Khin-Maugn-Gyi, F. What a Form 483 Really Means. Applied Clinical Trials Online, September 1, 2001.

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