Warning letter

TJA Health, LLC: warning letter of Jul 17, 2024

FDA warning letter 678539 · Division of Pharmaceutical Quality Operations III

Key facts

Reference number 678539
Company TJA Health, LLC
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Jul 17, 2024
Posted date Sep 17, 2024
Issuing office Division of Pharmaceutical Quality Operations III
Product type Drugs
CFR sections cited 211.34, 211.22(a), 211.84(d)(1)
Inspection city Joliet
Inspection ZIP 60436
Inspection start date Jan 25, 2024
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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