Warning letter

General Medical Company: warning letter of Jun 2, 2016

FDA warning letter 487535 · Los Angeles District Office

Key facts

Reference number 487535
Company General Medical Company
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jun 2, 2016
Posted date Jun 28, 2016
Issuing office Los Angeles District Office
Product type Tobacco
CFR sections cited 807.81(a)(3)(i), 803, 801.109(a)(2), 801.109(b)(1), 820
Inspection city Jacksonville
Inspection ZIP 32256
Inspection start date Oct 21, 2015
Letter on fda.gov web.archive.org

At a glance

  • 1–9 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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