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Getting Inspected

The US Food and Drug Administration (US FDA) conducts on-site inspections prior to approving a product for the US market. For drug products, these inspections are called Pre-Approval Inspections or PAIs. Once a product is available for commercial sale the FDA will conduct a Post-Approval Inspection. The US FDA will conduct general inspections every 2-3 years to ensure that the firm remains in compliance with US regulations.  The FDA regulates all firms that wish to sell, market, or distribute in the United States. If you plan to market or sell FDA regulated products in the United States, then plan on being inspected by the US FDA. 

Does this apply to foreign manufacturers? 

Yes, absolutely. While the FDA can not legally shut down a foreign manufacturer (or distributor) they can keep you from importing goods into the United States or offering goods for sale. In short, the U.S. FDA can restrict the importation and marketing of foreign goods into the US. The FDA routinely inspects foreign manufacturers to ensure proper regulations are being followed.

How we can help: Inspection Readiness

We perform Inspection Readiness Activities for both small and large firms. Our clients include pharmaceutical companies, medical device manufacturers, Combination product manufacturers, Contract Service Providers (CSPs), laboratories, GMP warehouses, and distributors. Inspection Readiness Activities include gap assessments, Subject Matter Expert (SME) readiness training, Mock FDA PAI Inspections, review of submission files, and site cGxP training.

We work with clients for successful pre-approval and post-approval inspections.

Some of Our Work

PAI Readiness for a Biosimilar Product

Our Client 1

The client had already performed a baseline gap assessment and asked us to come in to complete the activities and remediate any gaps. We worked with each key functional area to ensure that they were: (1) Complaint with FDA Regulations (2) In alignment with their filing to US FDA (3) were able to effectively communicate their testing, manufacturing, and validation strategies.

PAI Readiness for a Device Manufacturer

Our Client 2

We worked with a large medical device manufacturer to assist the with their Pre-Approval Inspection (PAI). We performed interviews for key subject-matter experts, we reviewed cleaning validation, process validation, and design validation files. We also assisted with the backroom during the inspection to ensure that the necessary documents were ready for the FDA.

PAI Readiness for a Distributor

Our Client 3

We worked with a foreign manufacturer to ensure that their US distributor and importer were ready for the US FDA. This distributor was key to ensuring their product reached the US market. After readiness items were completed the client also asked us to assist during the inspection. The FDA inspection was successful with no 483 observations.

Why choose Exemplar?

We provide a holistic approach to inspection readiness, ensuring that the quality system, product and manufacturing process are ready for an FDA inspection. Clients are able to gain valuable insight and knowledge while working side by side with Former FDA and Industry Experts.

PAI Readiness review activities may include:

  • FDA Application
  • Product specifications and manufacturing requirements
  • Quality system
  • Quality records
  • Clinical data
  • Supporting GXP systems
  • Interviews with key employees (SMEs) that will likely be interviewed by FDA during an inspection
  • On-site PAI Readiness Training (as/if required)

Contact us today for a free initial consultation.

We would love to hear about your project.

Contact Us