FDA 483 RESOLUTION CONTACT FORM

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MEDICAL CLINIC NAME:

CLINIC STAFF FULL NAME:

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CLINIC STAFF POSITION:

CLINIC ADDRESS:

PHONE NUMBER:

EMAIL:

CLINIC WEBSITE:

PAYMENT TYPE:

START DATE OF INTEREST:

FDA 483 / Warning Letter

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ASSESSMENT

1.How long has your site been operational?

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2. What is the size of your clinic staff working on clinical trials?

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3. Has your site ever received an FDA 483 or Warning Letter? If so, please confirm which type and provide details.

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4. When was the last FDA inspection at the site?

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5. Was the outcome of the most recent FDA findings pertaining to the site or staff specific? Please confirm which type and provide details.

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6. Does your site have a system in place for tracking and trending FDA 483 observations and deficiencies to identify recurring patterns or systemic issues?

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7. How does your site typically address FDA inspectional findings?

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8.Please quantify the number of FDA audits your site has undergone in the past 3 years?

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9. What are your site's current quality management systems for ensuring compliance with FDA regulations?

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10. How does your site promote a culture of compliance among its staff?

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11. What training does your site provide to staff on FDA regulations and compliance practices?

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12. Does the clinic have a budget set in place for contracting Vendors for site development and FDA Inspection support ?If yes, please provide the budget amount.

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13. What incentives or rewards does your site offer to staff for maintaining compliance?

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14. How does your site address instances of non-compliance among its staff?

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