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A Warning Letter on FDAs Expansive Interpretation of Its Facilities-Inspection Authority
Topic: Workplace Regulation
By James P. Ellison and Anne K. Walsh are Directors with the law firm Hyman, Phelps & McNamara, P.C.; Andrew J. Hull is an Associate with the firm.
Legal Backgrounder, March 13, 2015, 1 pages
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Publication Summary:

PUBLICATION SUMMARY

With a new guidelines on inspections, the Food and Drug Administration has handed itself intrusive new power beyond what Congress provided it in federal law. This paper critiques the guidelines and offers guidance of its own on how to avoid inspection pitfalls.
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