Warning letter

Quasar Bio-Tech, Inc. dba Silver Bay LLC [ARCHIVED]: warning letter of Dec 9, 2011

FDA warning letter 179355 · Florida District Office

Key facts

Reference number 179355
Company Quasar Bio-Tech, Inc. dba Silver Bay LLC [ARCHIVED]
Subject Premarket Approval/Misbranded/Adulterated
Issue date Dec 9, 2011
Posted date Dec 9, 2011
Issuing office Florida District Office
Product type Devices
CFR sections cited 807.97, 807.81(a)(3)(i), 807.81(b)
Inspection city Yorba Linda
Inspection ZIP 92886
Inspection start date Feb 2, 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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