Warning letter

Avena Botanicals, Inc.: warning letter of Nov 3, 2014

FDA warning letter 435131 · New England District Office

Key facts

Reference number 435131
Company Avena Botanicals, Inc.
Subject CGMP/Dietary Supplement/Adulterated/Misbranded
Issue date Nov 3, 2014
Posted date Nov 3, 2014
Issuing office New England District Office
Product type Food/Cosmetics
CFR sections cited 101.36, 111, 111.70(a), 111.70(b)(1), 111.70(b)(2), 111.70(b)(3), 111.70(e), 111.205(a), 111.255(b), 111.260(b), 111.260(h), 111.260(j) and 8 more
Inspection city Rockport
Inspection ZIP 04856
Inspection start date May 22, 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:

Browse all FDA warning letters