Warning letter

LifeCell Corporation: warning letter of Jun 1, 2015

FDA warning letter 459704 · Center for Devices and Radiological Health

Key facts

Reference number 459704
Company LifeCell Corporation
Subject Medical Device/Adulterated/Misbranded
Issue date Jun 1, 2015
Posted date Jun 1, 2015
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 807.81(a)(3)(ii), 878.3300, 807.81(b)
Inspection city Branchburg
Inspection ZIP 08876
Inspection start date May 6, 2015
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • NAI Linked inspection classification
  • No 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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