Warning letter

Crystal Care International Inc [ARCHIVED]: warning letter of May 22, 2009

FDA warning letter 48163 · Florida District Office

Key facts

Reference number 48163
Company Crystal Care International Inc [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date May 22, 2009
Posted date May 22, 2009
Issuing office Florida District Office
Product type Devices
CFR sections cited 874.3300, 803, 820
Inspection city Lutz
Inspection ZIP 33549
Inspection start date Dec 9, 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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