Warning letter

Pinook-USA: warning letter of Jun 14, 2012

FDA warning letter 292797 · Florida District Office

Key facts

Reference number 292797
Company Pinook-USA
Subject Medical Device/Adulterated/Misbranded
Issue date Jun 14, 2012
Posted date Jun 14, 2012
Issuing office Florida District Office
Product type Devices
CFR sections cited 803, 803.17, 820, 807.81(b)
Inspection city Orlando
Inspection ZIP 32837
Inspection start date Feb 23, 2012
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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