Warning letter

Hawaii Pharm LLC: warning letter of Apr 24, 2020

FDA warning letter 599389 · Division of Human and Animal Food Operations West V

Key facts

Reference number 599389
Company Hawaii Pharm LLC
Subject CGMP/Dietary Supplement/Adulterated/Misbranded
Issue date Apr 24, 2020
Posted date May 5, 2020
Issuing office Division of Human and Animal Food Operations West V
Product type Food/Cosmetics
CFR sections cited 101.4(h)(1), 11, 101, 101.36, 111, 101.4(g), 111.70(b), 111.70(b)(1), 111.70(e), 111.83(a), 111.83(b)(3), 111.205(a) and 7 more
Inspection city Honolulu
Inspection ZIP 96817
Inspection start date Oct 30, 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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