Warning letter

Sam-Go Products [ARCHIVED]: warning letter of Aug 24, 2011

FDA warning letter 198152 · Dallas District Office

Key facts

Reference number 198152
Company Sam-Go Products [ARCHIVED]
Subject CGMP/QSR/Medical Device Reporting/Adulterated
Issue date Aug 24, 2011
Posted date Aug 24, 2011
Issuing office Dallas District Office
Product type Devices
CFR sections cited 801.1, 803, 803.17, 820, 807.81(b)
Inspection city Lakeside
Inspection ZIP 76135
Inspection start date Mar 8, 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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