Warning letter

Marco Pharma International LLC: warning letter of Jan 10, 2020

FDA warning letter 585324 · Division of Human and Animal Food Operations West VI

Key facts

Reference number 585324
Company Marco Pharma International LLC
Subject CGMP/Dietary Supplement/Adulterated/Misbranded
Issue date Jan 10, 2020
Posted date Feb 4, 2020
Issuing office Division of Human and Animal Food Operations West VI
Product type Food/Cosmetics
CFR sections cited 111.210(h)(3), 101, 101.4, 101.36, 111, 111.55, 111.70, 111.73, 111.103, 111.105, 111.210, 111.260 and 20 more
Inspection city Roseburg
Inspection ZIP 97470
Inspection start date May 14, 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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