Warning letter

SnugZ USA, Inc.: warning letter of Sep 28, 2026

FDA warning letter 735284 · Center for Drug Evaluation and Research (CDER)

Key facts

Reference number 735284
Company SnugZ USA, Inc.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Sep 28, 2026
Posted date Oct 20, 2026
Issuing office Center for Drug Evaluation and Research (CDER)
Product type Drugs
CFR sections cited 211.160(b), 211.192, 211.188(b), 211.180(e), 211.22, 211.22(d), 211.34, 211.67(b), 211.84(d)(1)
Inspection city West Jordan
Inspection ZIP 84081
Inspection start date Apr 27, 2026
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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