ProPharma Supports A Contract Manufacturer's Form 483 Response

When faced with FDA 483 observations, swift and effective action is crucial. ProPharma's Quality & Compliance team is equipped to provide expert guidance and support throughout the entire response process.

Our recent experience assisting a contract manufacturer highlights our ability to mobilize quickly, assemble a skilled team, and deliver comprehensive solutions. We successfully addressed a range of issues, including incomplete validations, inadequate document control, and deviation management.

By leveraging our in-house expertise and scalable approach, we helped the client develop a holistic remediation plan, implement corrective actions, and achieve a successful outcome. Trust ProPharma to guide you through FDA 483 observations with confidence.