Warning letter

Sagami Rubber Industries Co., Ltd.: warning letter of Nov 24, 2015

FDA warning letter 481765 · Center for Devices and Radiological Health

Key facts

Reference number 481765
Company Sagami Rubber Industries Co., Ltd.
Subject Medical Device Reporting/Misbranded
Issue date Nov 24, 2015
Posted date Jan 19, 2015
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 803, 803.17
Inspection city Atsugi
Inspection start date Jul 21, 2015
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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