Warning letter

Abbott's Compounding Pharmacy, Inc.: warning letter of Apr 4, 2017

FDA warning letter 506776 · San Francisco District Office

Key facts

Reference number 506776
Company Abbott's Compounding Pharmacy, Inc.
Subject Compounding Pharmacy/Adulterated Drug Products
Issue date Apr 4, 2017
Posted date Apr 4, 2017
Issuing office San Francisco District Office
Product type Drugs
CFR sections cited 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.56(a), 201.115, 211, 211.28(a), 211.42(b), 211.42(c)(10)(iii)
Inspection city Berkeley
Inspection ZIP 94705
Inspection start date Dec 29, 2015
Letter on fda.gov fda.gov

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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