Warning letter

Ionia Pharmacy: warning letter of Dec 22, 2015

FDA warning letter 481357 · Los Angeles District Office

Key facts

Reference number 481357
Company Ionia Pharmacy
Subject CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Issue date Dec 22, 2015
Posted date Jan 12, 2016
Issuing office Los Angeles District Office
Product type Drugs
CFR sections cited 201.115, 211, 211.28, 211.113, 211.166, 211.167, 200.10(b), 211.42(c)(10), 211.165(a), 210.1
Inspection city Tustin
Inspection ZIP 92780
Inspection start date Mar 3, 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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