Warning letter

So-Low Environmental Equipment Co. Inc.: warning letter of May 21, 2013

FDA warning letter 396959 · Cincinnati District Office

Key facts

Reference number 396959
Company So-Low Environmental Equipment Co. Inc.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date May 21, 2013
Posted date May 21, 2013
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 803, 803.17, 820
Inspection city Cincinnati
Inspection ZIP 45215
Inspection start date Apr 9, 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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