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483 and Warning Letter Remediation

EAS Consulting Group assists firms with preparation of responses to FDA in the event of a form 483 or Warning Letter or when the Department of Justice files a consent decree. Timely and thorough communication including acknowledgement and remediation plan to correct the observations are imperative.

An FDA Form 483 is issued when an investigation identifies any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts and notifies the company’s management of objectionable conditions.

Receipt of FDA Form 483s and Warning Letters must be taken seriously, and companies must take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist and communicate those actions to FDA.

Ensuring your response to FDA is timely, accurate and demonstrates corrective actions to be taken is paramount. EAS helps with preparation of responses, acting as a conduit of information between FDA and the recipient, and helps with CAPA development and execution so that firms are able to bring themselves into FDA compliance.

EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.

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