Warning letter

Atlas Pharmaceuticals, LLC: warning letter of Sep 10, 2018

FDA warning letter 564139 · San Francisco District Office

Key facts

Reference number 564139
Company Atlas Pharmaceuticals, LLC
Subject Compounding Pharmacy/Adulterated Drug Products
Issue date Sep 10, 2018
Posted date Sep 25, 2018
Issuing office San Francisco District Office
Product type Drugs
CFR sections cited 211.188, 201.115, 211.192, 200.10(b), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.67(a), 211.113(b), 211.160(b), 210.1(b)
Inspection city Phoenix
Inspection ZIP 85085
Inspection start date Aug 15, 2017
Letter on fda.gov fda.gov

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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