Warning letter

Burnham Laboratories, Inc.: warning letter of Oct 15, 2001

FDA warning letter UCM178322 · Chicago District Office

Key facts

Reference number UCM178322
Company Burnham Laboratories, Inc.
Subject Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated
Issue date Oct 15, 2001
Posted date Oct 15, 2001
Issuing office Chicago District Office
Product type Drugs
CFR sections cited 211.84(d)(2), 211.67(b), 211
Country 3
Inspection city Niles
Inspection ZIP 60714-4617
Inspection start date Aug 21, 2001
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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