April 14, 2026 FDA Warning Letter: Ava Inc. Cited for CGMP/Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at Ava Inc.

WARNING LETTER Ava Inc. MARCS-CMS 721180 — April 14, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-26-64 Product: Drugs Recipient: Recipient Name Dr. Ram P. Chakroborty Recipient Title President & Chief Executive Officer Ava Inc. 7051 S. Adams St. Willowbrook , IL 60527-7592 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-64 April 14, 2026 Dear Dr. Ram P. Chakroborty: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Ava Inc., FEI 3008736380, at 7051 S. Adams St., Willowbrook, IL, from October 6 to October 21, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211), and significant deviations from CGMP for active pharmaceutical ingredients (APIs). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drugs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your November 12, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations and deviations including, but not limited to, the following. Finished Drug CGMP Violations 1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm lacked adequate system security and access controls over your laboratory equipment used to test drug products prior to release. For example, your firm utilized a common username and password to access high performance liquid chromatography (HPLC) equipment used for impurity testing of drug products. Additionally, analysts had administrator privileges to modify and delete data. Our investigators also found multiple deleted gas chromatography (GC) analytical sequences in the recycle bin, including sequences used for system suitability and stability analysis. In your response, you state your employee violated your procedure and training by deleting sequence files without informing the supervisor or quality assurance (QA). You also state a software update allowed users to bypass “User-Security Access Restrictions” and that you have disabled the automatic software update function. You also state that you have implemented security parameters to enhance access controls to electronic data files. Your response is inadequate. You do not provide adequate details of management oversight to ensure effectiveness of the corrective actions implemented. You also lack a comprehensive assessment of all electronic and paper-based documentation systems to ensure their adequacy. In response to this letter, provide: A complete, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation. A comprehensive, independent assessment of computer system security and integrity. Provide a report that identifies vulnerabilities in the design and controls and a thorough CAPA plan for each of your laboratory computer systems and that addresses the following elements: o A list of all hardware (both standalone and networked) and software used by your laboratory. o Identify and evaluate vulner