Warning letter

Sportron International, Inc.: warning letter of Aug 23, 2019

FDA warning letter 579475 · Office of Human and Animal Food West Division 3

Key facts

Reference number 579475
Company Sportron International, Inc.
Subject Unapproved New Drugs/Misbranded
Issue date Aug 23, 2019
Posted date Sep 3, 2019
Issuing office Office of Human and Animal Food West Division 3
Product type Food/Cosmetics
CFR sections cited 111, 111.73, 111.75, 111.103, 111.70(b)(1), 111.70(b)(2), 111.70(f), 111.70(g), 111.95(b)(1), 111.127(h), 111.140(b)(2), 111.140(b)(3) and 2 more
Inspection city Whitewright
Inspection ZIP 75491
Inspection start date Mar 22, 2019
Letter on fda.gov fda.gov

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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