Warning letter

NeoChild LLC: warning letter of Jul 29, 2008

FDA warning letter UCM1048196 · Dallas District Office

Key facts

Reference number UCM1048196
Company NeoChild LLC
Subject CGMP for Medical Devices/QS/Adulterated
Issue date Jul 29, 2008
Posted date Jul 29, 2008
Issuing office Dallas District Office
Product type Devices
CFR sections cited 803, 803.17, 820, 820.1(a)(3), 807.81(b)
Country 3
Inspection city Oklahoma City
Inspection ZIP 73128-9527
Inspection start date Apr 17, 2008
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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