Warning letter

Tosoh Biosciences, Inc. [ARCHIVED]: warning letter of Jan 18, 2011

FDA warning letter 124848 · Cincinnati District Office

Key facts

Reference number 124848
Company Tosoh Biosciences, Inc. [ARCHIVED]
Subject Premarket Approval/Adulterated/Misbranded
Issue date Jan 18, 2011
Posted date Jan 18, 2011
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 820.3(b), 807.81(b), 803, 806, 820
Inspection city Grove City
Inspection ZIP 43123
Inspection start date Mar 23, 2010
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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