Review of Allegations of Mismanagement at the Food and Drug Administration - Newark District Office

EXECUTIVE SUMMARY:

The final audit report provides the results of our review of alleged mismanagement at the Food and Drug Administration (FDA), Newark District Office (NDO). Congressman John D. Dingell, Chairman, House Subcommittee on Oversight and Investigations (Subcommittee), Committee on Energy and Commerce, requested that the Office of Inspector General conduct an audit of NDO to: (1) determine if the alleged improper management practices in that office have hindered the enforcement of the Federal Food, Drug, and Cosmetic Act; and (2) render an opinion on whether such practices inhibit the proper inspection of pharmaceutical manufacturers and other firms regulated by FDA. We found no evidence to support allegations that NDO management inhibited the proper inspection of generic drug manufacturers and other firms regulated by FDA. We identified a high turnover rate at NDO, however, we found no documentation to support the contention that improper or incompetent management caused qualified investigators to seek other employment. Also, we found no documentation that NDO management mistreated one investigator or hindered attempts to complete an inspection.