Warning letter

Formulife, Inc.: warning letter of Jun 17, 2013

FDA warning letter 382320 · Dallas District Office

Key facts

Reference number 382320
Company Formulife, Inc.
Subject Unapproved New Drug/Adulterated/Misbranded
Issue date Jun 17, 2013
Posted date Jun 17, 2013
Issuing office Dallas District Office
Product type Food/Cosmetics
CFR sections cited 101.36, 101.4(h)(1), 101.4(g), 101.9(c)(8)(iii), 101.36(b)(2)(i), 101.36(b)(3)(ii), 101.36(c)(1), 101.9(c), 101.36(c)(2), 101
Inspection city Allen
Inspection ZIP 75002
Inspection start date Aug 1, 2012
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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