PharmQS guide pharmaceutical companies with preparation of responses to FDA in the event of a form 483 or Warning Letter. Ensuring your response to FDA is timely, accurate and demonstrates corrective/preventive actions to be taken is paramount.
Receipt of FDA 483 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.
PharmQS also act as a third-party for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.