Warning letter

Dakota Laboratories, Llc [ARCHIVED]: warning letter of Mar 17, 2011

FDA warning letter 131410 · Minneapolis District Office

Key facts

Reference number 131410
Company Dakota Laboratories, Llc [ARCHIVED]
Subject CGMP for Finished Pharmaceuticals/Adulterated
Issue date Mar 17, 2011
Posted date Mar 17, 2011
Issuing office Minneapolis District Office
Product type Drugs
CFR sections cited 211.111, 211.113(b), 211.42(c)(10)(iv), 211.192
Inspection city Mitchell
Inspection ZIP 57301
Inspection start date Jun 22, 2010
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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