CGMP Violations at TJA Health

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 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.