Warning letter

Zoll Manufacturing Corp.: warning letter of Sep 23, 2014

FDA warning letter 436320 · Philadelphia District Office

Key facts

Reference number 436320
Company Zoll Manufacturing Corp.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Sep 23, 2014
Posted date Sep 23, 2014
Issuing office Philadelphia District Office
Product type Devices
CFR sections cited 803.50(a), 803, 803.3, 803.17, 803.50(a)(1), 803.50(a)(2), 820
Country 1
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited

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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