Warning letter

Cellestis Inc: warning letter of Aug 26, 2015

FDA warning letter 458031 · Los Angeles District Office

Key facts

Reference number 458031
Company Cellestis Inc
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Aug 26, 2015
Posted date Sep 8, 2015
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 803, 803.3, 803.17, 803.50, 803.53, 806, 806.20, 803.50(a)(2), 803.52(e)(4), 820, 803.50(a), 803.50(b) and 1 more
Inspection city Santa Clarita
Inspection ZIP 91355
Inspection start date Mar 17, 2015
Letter on fda.gov web.archive.org

At a glance

  • 10–99 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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