Warning letter

The W.S. Badger Company, Inc.: warning letter of Apr 12, 2022

FDA warning letter 622318 · Division of Pharmaceutical Quality Operations I

Key facts

Reference number 622318
Company The W.S. Badger Company, Inc.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Apr 12, 2022
Posted date May 3, 2022
Issuing office Division of Pharmaceutical Quality Operations I
Product type Drugs
CFR sections cited 211.192, 211.165(e), 211.34, 211.100(a)
Inspection city Gilsum
Inspection ZIP 03448
Inspection start date Aug 30, 2021
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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