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# CGMP Violations at TJA Health
- URL: https://www.fdaweb.com/cgmp-violations-at-tja-health/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157787

A 1/25-1/29 FDA inspection at the TJA Health drug manufacturing facility in Joliet, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/17 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tja-health-llc-678539-07172024?ref=fdaweb.com) says the specific violations were:

- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality; and
- failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA recommended that the firm engage a qualified consultant to assist it in meeting CGMP requirements. TJA Health was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrective actions.