Warning letter

Sage Products Inc: warning letter of Jul 17, 2017

FDA warning letter 520382 · Detroit District Office

Key facts

Reference number 520382
Company Sage Products Inc
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Jul 17, 2017
Posted date Jul 25, 2017
Issuing office Detroit District Office
Product type Drugs
CFR sections cited 211.160(b), 210, 211.67(a), 211.165(e)
Inspection city Cary
Inspection ZIP 60013
Inspection start date Jun 2, 2016
Letter on fda.gov fda.gov

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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