Warning letter

Option Care: warning letter of Sep 28, 2017

FDA warning letter 538040 · Detroit District Office

Key facts

Reference number 538040
Company Option Care
Subject Drug Product/Adulterated
Issue date Sep 28, 2017
Posted date Sep 28, 2017
Issuing office Detroit District Office
Product type Drugs
Inspection city Wood Dale
Inspection ZIP 60191
Inspection start date Sep 1, 2016
Letter on fda.gov fda.gov

At a glance

  • 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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