A Warning Letter on FDA’s Expansive Interpretation of Its Facilities – Inspection Authority

March 13, 2015

In this Legal Backgrounder published by the Washington Legal Foundation, HPM authors write a “Warning Letter” to FDA-regulated drug establishments regarding FDA’s inspection practices. This article addresses several of the unresolved questions regarding FDA’s inspection authority and aggressive inspection practices, as discussed in FDA’s Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (2014).

Additional information available here.