Warning letter

Pharmco Laboratories Inc.: warning letter of Dec 15, 2016

FDA warning letter 486901 · Florida District Office

Key facts

Reference number 486901
Company Pharmco Laboratories Inc.
Subject CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Issue date Dec 15, 2016
Posted date Jan 31, 2017
Issuing office Florida District Office
Product type Drugs
CFR sections cited 201.327(e)(1)(ii), 352, 352.10, 211.100(a), 211.160(b), 211.166(a), 201.327, 201.327(d)(2), 201.327(e), 211.165(e), 330.1(c)(2), 333.350(b) and 3 more
Inspection city Titusville
Inspection ZIP 32780
Inspection start date Nov 9, 2015
Letter on fda.gov web.archive.org

At a glance

  • 10–99 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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