Warning letter

Steris Corporation: warning letter of Nov 29, 2006

FDA warning letter UCM076189 · New Orleans District Office

Key facts

Reference number UCM076189
Company Steris Corporation
Subject Medical Device Reporting (MDR) Regulation Misbranded/Adulterated
Issue date Nov 29, 2006
Posted date Nov 29, 2006
Issuing office New Orleans District Office
Product type Devices
CFR sections cited 806.10(a)(1), 806.2(d), 803, 806, 806.10, 803.22(b)(2), 803.50(a)(2)
Country 3
Inspection city Montgomery
Inspection ZIP 36109-1410
Inspection start date Jun 5, 2006
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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