Warning letter

Elmec Industries, Inc.: warning letter of Aug 31, 2015

FDA warning letter 461345 · San Juan District Office

Key facts

Reference number 461345
Company Elmec Industries, Inc.
Subject Food Labeling/Misbranded
Issue date Aug 31, 2015
Posted date Sep 29, 2015
Issuing office San Juan District Office
Product type Food/Cosmetics
CFR sections cited 101, 101.4, 101.4(b)(2), 101.4(b)(4), 101.56(b)(3)(i), 101.9, 101.13(j)(2), 101.22(j), 101.56(b), 101.56(b)(2), 101.56(b)(3)(ii), 101.60(b)(2) and 1 more
Inspection city Mayaguez
Inspection ZIP 00680
Inspection start date Mar 2, 2015
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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