Warning letter

Tibetan Herbal Balance, Inc.: warning letter of Jan 4, 2016

FDA warning letter 451629 · New England District Office

Key facts

Reference number 451629
Company Tibetan Herbal Balance, Inc.
Subject Unapproved New Drugs/Misbranded
Issue date Jan 4, 2016
Posted date Jan 4, 2016
Issuing office New England District Office
Product type Food/Cosmetics
CFR sections cited 111, 111.127, 111.520, 111.15(i), 111.70(f), 111.210(g), 111.210(h)(3), 111.535(b)(1), 111.535(b)(2), 111.75(e), 201.5
Inspection city Malden
Inspection ZIP 02148
Inspection start date Dec 18, 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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