FDA Compounder Inspections May Help Set New Enforcement Standard

Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.

An early batch of FDA compounder inspections following the high-profile meningitis outbreak may signal what awaits other compounders if the agency gains more oversight authority.

There already is growing pressure on FDA and state regulators to gain control of compounding industry practices in the wake of the problems at the New England Compounding Center that resulted in contaminated

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