Warning letter

Protech Professional Products, Inc.: warning letter of Jul 24, 2014

FDA warning letter 420411 · Florida District Office

Key facts

Reference number 420411
Company Protech Professional Products, Inc.
Subject Premarket Approval/Adulterated
Issue date Jul 24, 2014
Posted date Jul 24, 2014
Issuing office Florida District Office
Product type Devices
CFR sections cited 820, 803, 807.81(a)(3)(i), 807.81(b)
Inspection city Boynton Beach
Inspection ZIP 33426
Inspection start date Dec 11, 2013
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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