Warning letter

Tosoh Bioscience Inc: warning letter of Aug 5, 2016

FDA warning letter 505636 · Cincinnati District Office

Key facts

Reference number 505636
Company Tosoh Bioscience Inc
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Aug 5, 2016
Posted date Aug 5, 2016
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 820
Inspection city Grove City
Inspection ZIP 43123
Inspection start date May 16, 2016
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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