Warning letter

US Pharmaceuticals Inc.: warning letter of Jun 6, 2019

FDA warning letter 573233 · Division of Pharmaceutical Quality Operations I

Key facts

Reference number 573233
Company US Pharmaceuticals Inc.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Jun 6, 2019
Posted date Jul 9, 2019
Issuing office Division of Pharmaceutical Quality Operations I
Product type Drugs
CFR sections cited 211.34, 211.63, 211.192, 211.160(b)
Inspection city South Plainfield
Inspection ZIP 07080
Inspection start date Oct 31, 2018
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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