• Global Audits Banner2a
  • Global Audits

 
 
 

FDA Vendor-Supplier Audits

The FDA is becoming increasingly more vigilant in tracking quality issues throughout the entire drug manufacturing supply chain. In the business world, a company ultimately is only as good (or bad) as its best or worst supplier. This places increased emphasis on the importance of vendor audits and supplier audits to evaluate your supplier’s quality management system, as well as its products, practices and documentation.

By partnering with USDM, we can provide certified auditors who are knowledgeable and industry experienced. Our vendor audit services can assist you in maintaining your vendor qualification program, maintaining your approved vendors or approved suppliers list and executing supplier audits on a scheduled basis or as part of for-cause investigations.

USDM vendor audits and supplier audits are conducted by a team of quality compliance professionals and all audits are followed by a detailed audit report with all audit observations and findings characterized as to their significance to your quality program.

Examples include:

  • Suppliers of Direct Contact Drug Components including ISO-10993/USP XXVII, Class 6 Tubing
  • BSE/TSE Verification of Drug Ingredients, Components & Product Contact Lubricants
  • Sterile / Non-Sterile environments