Firms handling controlled drug substances are regulated under 21CFR Part 1300-1321 and must comply with all associated DEA regulations. The DEA (Drug Enforcement Administration) oversees all places of business that handle controlled drug substances. DEA Investigators may conduct an unannounced inspection of a facility for a routine audit or if there is a concern about diversion or record keeping practices. Whatever the reason, we can help prepare you for these inevitable audits. Our DEA experts (most of whom are former DEA Diversion Investigators) routinely conduct:

  • Pre-registration assessments
  • Internal company audits including evaluation of:
    • Receipt 
    • Storage 
    • Handling
    • Shipping 
    • Security 
    • Documentation
  • Contract manufacturing organization (CMO) audits 
  • Clinical site audits
  • Reverse distributor audits
  • Distribution partner audits (including 3PL)

In addition to audits, we can also provide on-site consulting and training.