Inspection Readiness

FDA to Begin Unannounced Inspections of Non-U.S. Manufacturing Facilities

Beginning August 2025, FDA inspections at non-U.S. manufacturing sites will take place without advance notice. This shift eliminates prior warning and signals a new standard for global regulatory oversight—one that demands continuous readiness.

With deep FDA expertise and regulatory professionals positioned around the world, ProPharma helps pharmaceutical, biotechnology, and medical device companies build and sustain inspection readiness—before the FDA arrives.

FDA to Begin Unannounced Inspections of Non-U.S. Manufacturing Facilities

Beginning August 2025, FDA inspections at non-U.S. manufacturing sites will take place without advance notice. This shift eliminates prior warning and signals a new standard for global regulatory oversight—one that demands continuous readiness.

With deep FDA expertise and regulatory professionals positioned around the world, ProPharma helps pharmaceutical, biotechnology, and medical device companies build and sustain inspection readiness—before the FDA arrives.

Inspection Readiness is not an option – now, more than ever, it is urgent.

Our team of experts is equipped to guide you through every step of any inspection your firm is facing, with experience and expertise. The overview below outlines how ProPharma supports clients through every stage of the inspection readiness lifecycle.

inspection-readiness-workflow-illustration

We ensure that every step towards Inspection Readiness is carefully calibrated to your needs. Our method is backed by tangible tools and training programs developed from the ground up, tailored not just to your product, but to your organization's unique scale and scope. This approach allows you to maintain focus on running your business, while we dedicate ourselves fully to your Inspection Readiness, making it our singular priority.

Inspection Readiness Experts

Unannounced inspections are coming. Preparation can't wait.

With global regulatory and quality expertise and a history of guiding clients through successful FDA inspections, ProPharma helps ensure your operations are always inspection ready—no matter when the FDA arrives.

Secure Your Regulatory Inspection Success

On average a new product takes approximately 10-15 years to develop, whether it is a biologic, a pharmaceutical product, a medical device, or a combination thereof.

  • Can you risk the time and resources you invested in development by ignoring the importance of Inspection Readiness for a new product?
  • Can you risk having an existing product off the market for remediation activities following a For Cause Inspection?
  • Can your patients?

ProPharma's expertise covers all aspects of Inspections. Inspection Readiness Evaluation, Project Management, your Inspection Program/Process, Logistics, and Training – are just some of the most important areas of Inspection Readiness. Our expertise can become your greatest asset. We are eager to become your partner in navigating this critical process.

Group of business professionals working at a conference table with laptops and clipboards
Group of medical professionals smiling in a common area

PAI Readiness

Pre-approval Inspections are one of the most critical inspections any Biologic, Pharmaceutical or Medical Device firm will undertake. Failure to meet FDA expectations can have a huge impact on organizations, including:

  • Delays to product launch.
  • Thousands, if not millions of dollars, in remediation costs.
  • Lost market share.
  • Loss of a firm's credibility.

PAI readiness is critical, and ProPharma is an industry leader in providing PAI Readiness to our clients.

BIMO Readiness

BIMO inspection readiness is essential for sponsors to ensure compliance with FDA regulations, protect data integrity, and uphold patient safety standards. By preparing thoroughly, sponsors:

  • Ensure compliance with FDA regulations.
  • Protect data integrity.
  • Uphold patient safety standards.
  • Help avoid costly delays.
  • Prevent potential compliance issues.
  • Facilitate smoother FDA inspections.
Healthcare provider looking into medical device

To date, we have had a 100% success rate on PAI Readiness projects for our clients

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