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TJA Health, LLC's drug manufacturing facility in Joliet, Illinois failed to comply with Current Good Manufacturing Practice (CGMP) regulations, rendering their finished pharmaceutical products adulterated. The company violated 21 CFR 211.84(d)(1) and 211.84(d)(2) by failing to perform required identity and conformity testing on incoming raw materials, including active pharmaceutical ingredients and high-risk components; instead, the firm relied solely on suppliers' certificates of analysis without conducting independent testing. The facility specifically failed to adequately test shipments for contamination risks including diethylene glycol (DEG) and ethylene glycol (EG), creating a significant quality control gap that left the company without scientific evidence that components met specifications before use in drug manufacturing.