Warning letter

New Vitalis, LLC dba New Vitalis Pharmacy: warning letter of May 18, 2022

FDA warning letter 633440 · Division of Pharmaceutical Quality Operations III

Key facts

Reference number 633440
Company New Vitalis, LLC dba New Vitalis Pharmacy
Subject Compounding Pharmacy/Adulterated Drug Products
Issue date May 18, 2022
Posted date May 31, 2022
Issuing office Division of Pharmaceutical Quality Operations III
Product type Drugs
Inspection city Louisville
Inspection ZIP 40213
Inspection start date Aug 23, 2021
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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