Warning letter

Apira Science, Inc.: warning letter of Apr 17, 2012

FDA warning letter 233517 · Los Angeles District Office

Key facts

Reference number 233517
Company Apira Science, Inc.
Subject Premarket Approval/Adulterated
Issue date Apr 17, 2012
Posted date Apr 17, 2012
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 820.40, 820, 807.81(b)
Inspection city Albuquerque
Inspection ZIP 87107
Inspection start date Aug 16, 2011
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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