Form 483 Clause Samples
The Form 483 clause outlines the procedures and obligations that arise when the U.S. Food and Drug Administration (FDA) issues a Form 483, which is a notice of inspectional observations to a company following an FDA inspection. This clause typically requires the recipient to promptly notify relevant parties, provide copies of the Form 483, and detail any planned or completed corrective actions. By establishing clear communication and response protocols, the clause ensures that all stakeholders are informed and that regulatory compliance issues are addressed efficiently, thereby minimizing potential business or legal risks.
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Form 483. During the 2 year period ending on the date of this Agreement, it has not received any FDA Form 483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters” or similar correspondence or written notice from the FDA or other governmental entity asserting material noncompliance with any applicable legal requirements. There are currently no outstanding FDA Form 483s with respect to it.
Form 483. The non-receiving party may terminate this Agreement upon ninety (90) days notice if the other party has received a Form 483 report regarding Product or the manufacturing facilities therefor and it has not complied with such Form 483 within a reasonable time thereafter and is not diligently pursuing corrective action in response thereto or is not actively contesting the deficiencies noted in the Form 483.
Form 483. A ''Form 483," otherwise known as a "Notice oflnspectional Observations," was issued by the FDA to sumarize the cGMP deficiencies observed by the FDA inspectors during a particular inspection.