August 14, 2023

Indiana contract research company discloses FCPA investigation

Inotiv, Inc. disclosed in a regulatory filing on August 11, 2023, that it had received a voluntary document request from the US Securities and Exchange Commission regarding possible violations of the US Foreign Corrupt Practices Act.  Inotiv, an Indiana company previously known as Bioanalytical Systems, Inc., provides “nonclinical and analytical drug discovery and development services” to medical device and drug manufacturers.  Its business includes the importation of non-human primates (“NHPs”) to the United States for pharmaceutical research.

In November 2022, several employees of Inotiv’s principal supplier of NHPs, along with two Cambodian government officials, were criminally charged by the US Attorney for the Southern District of Florida with conspiring to illegally import NHPs into the United States between December 2017 and September 2022.  In its SEC filing, Inotiv stated that the charges followed grand jury subpoenas to two Inotiv subsidiaries, Orient BioResource Center, Inc., and Envigo Global Services, Inc., for information about pre-acquisition transactions related to the procurement of NHPs from foreign suppliers, and their importation into the United States.

The SEC’s request for documents, received by Inotiv on May 23, 2023, focuses on NHP procurement and importation between December 1, 2017 and the present, and, as described by Inotiv, includes requests relating to whether the Company’s importation practices complied with the FCPA.

Inotiv stated that it is cooperating fully with both the criminal investigation by the US Attorney’s Office for the Southern District of Florida and the recent document request by the SEC.

Form 10-Q