Big Horn Safety, LLC provides expert auditing and consulting services for industries that must comply with FDA cGMP regulations.  Our services should enhance your company’s ability to comply with FDA regulations. 

 

Lack of findings in different operational systems during a Big Horn Safety audit, however, does not imply that other non-conformities do not exist. FDA personnel could potentially observe audit observations not revealed during an external audit with Big Horn Safety LLC.  Big Horn Safety LLC, therefore, cannot guarantee that your company will not receive FDA regulatory actions upon a federal inspection. Big Horn Safety LLC cannot be held liable in any manner for your company's lack of compliance with federal standards.

 

Your company must perform due diligence to optimize cGMP compliance at all times, in all systems and in all processes of manufacturing.  Your company should continue to perform both internal and external cGMP audits to enhance your compliance with FDA regulations and to maintain uninterrupted commerce of your product. 

 

Big Horn Safety LLC is here to help your company.  We are a mission-based company promoting safety and public health. We want your processes to be safe and in compliance with current good manufacturing practices.  We wish you success in all of these endeavors.