TJA Health, LLC – FDA Warning Letter, Jan 29, 2024

On July 17, 2024, the FDA issued a Warning Letter to TJA Health LLC following an inspection from January 25-29, 2024, at their Joliet, IL facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** TJA Health LLC released active pharmaceutical ingredients (API) and high-risk components (e.g., glycerin, sorbitol in Plaque HD Toothpaste and Plaque Remineralizing Mouth Rinse) based solely on supplier COAs, without performing identity tests, including specific limit tests for diethylene glycol (DEG) or ethylene glycol (EG) as required by USP. The firm also failed to adequately monitor their (b)(4) water system for *Burkholderia cepacia complex* (BCC), a risk for non-sterile, water-based drug products. The firm's response was deemed inadequate as it lacked DEG/EG limit testing and a comprehensive water system assessment. 2. **Inadequate Quality Control Unit (21 CFR 211.22(a)):**