Warning letter

Prime Health Products: warning letter of Jul 29, 2015

FDA warning letter 454614 · Center for Food Safety and Applied Nutrition

Key facts

Reference number 454614
Company Prime Health Products
Subject Unapproved New Drug/Misbranding/Adulterated
Issue date Jul 29, 2015
Posted date Aug 18, 2015
Issuing office Center for Food Safety and Applied Nutrition
Product type Food/Cosmetics
CFR sections cited 101, 101.36, 111, 111.255, 111.260, 101.4(h)(1), 111.70(b)(2), 111.70(e), 111.210(h)(2), 111.260(j)(2)(iv), 111.75(c), 701.13(b)
Inspection city Etobicoke
Inspection start date Sep 8, 2014
Letter on fda.gov web.archive.org

At a glance

  • 10–99 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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