Warning letter

Hillestad Pharmaceuticals USA, Inc.: warning letter of Apr 17, 2013

FDA warning letter 360978 · Minneapolis District Office

Key facts

Reference number 360978
Company Hillestad Pharmaceuticals USA, Inc.
Subject CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Issue date Apr 17, 2013
Posted date Apr 17, 2013
Issuing office Minneapolis District Office
Product type Food/Cosmetics
CFR sections cited 111, 111.210, 111.75(h)(1), 111.210(h)(2), 111.210(h)(5), 111.75(c), 111.75(c)(3)
Inspection city Woodruff
Inspection ZIP 54568
Inspection start date May 25, 2012
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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