Why is my facility ineligible for Supply Chain Inspection?

You may be ineligible for the Supply Chain Inspection because of your facility’s business model. Current eligible facilities include:

  • prescription drug wholesale distributors,
  • prescription medical device distributors,
  • active pharmaceutical ingredient (API) distributors,
  • API repackagers,
  • repackagers of finished prescription drugs,
  • veterinary prescription drug distributors,
  • reverse distributors,
  • sample distributors,
  • investigational drug distributors,
  • manufacturers,
  • virtual distributors and manufacturers, and
  • third-party logistics (3PL) providers.

Business models that are not eligible include FDA-registered outsourcing facilities (503B) and over-the-counter medical device distributors.

Alternatively, your facility may be deemed ineligible because information is incomplete within its business e-Profile. In this instance, please ensure the following fields have been provided within the e-Profile:

  • demographic information (doing business as, business address, business email, website, etc.),
  • contacts,
  • ownership (unless publicly traded),
  • activities,
  • licenses,
  • supply chain (sources and customers),
  • business hours,
  • storefront, and
  • schematic.

Please review and ensure all required fields are completed.