Warning letter

Custom Compounding Centers, LLC: warning letter of May 15, 2013

FDA warning letter 391363 · Los Angeles District Office

Key facts

Reference number 391363
Company Custom Compounding Centers, LLC
Subject Unapproved and Misbranded New Drugs
Issue date May 15, 2013
Posted date May 15, 2013
Issuing office Los Angeles District Office
Product type Drugs
CFR sections cited 201.115, 211, 211.192, 211.42(c)(10)(iii), 211.42(c)(10)(iv), 211.113(b), 211.166(a)
Inspection city Los Alamitos
Inspection ZIP 90720
Inspection start date Nov 14, 2012
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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