FDA WARNING_LETTER - Ava Inc - October 21, 2025

The FDA issued a Warning Letter to Ava Inc. following an inspection of its Willowbrook, Illinois facility from October 6 to October 21, 2025. The investigation revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR Parts 210 and 211) and active pharmaceutical ingredients. The FDA concluded that the company"s products are adulterated because their manufacturing and testing processes do not meet federal standards. Key issues included a lack of control over computer systems, such as the use of shared passwords and allowing analysts to delete analytical data. Investigators also discovered the practice of performing "trial injections," where samples were tested repeatedly until favorable results were obtained, while failing results were ignored or not investigated. Furthermore, the Quality Unit failed to provide adequate oversight, often allowing personnel to bypass established procedures. To address these deficiencies, the FDA requires Ava Inc. to conduct comprehensive, independent assessments of their documentation and computer security systems. The company must also perform a retrospective review of past testing data to ensure product safety. The FDA strongly recommends hiring a qualified consultant and an independent third party to oversee a global data integrity remediation plan. Ava Inc. must respond within 15 working days with a detailed corrective action plan.