Warning letter

Rainbow LTD, Inc. dba PN Medical [ARCHIVED]: warning letter of Nov 1, 2011

FDA warning letter 213973 · Florida District Office

Key facts

Reference number 213973
Company Rainbow LTD, Inc. dba PN Medical [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Nov 1, 2011
Posted date Nov 1, 2011
Issuing office Florida District Office
Product type Devices
CFR sections cited 803, 803.17, 807.81(a)(3)(ii), 820, 807.81(b)
Inspection city Orlando
Inspection ZIP 32801
Inspection start date Jun 23, 2011
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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