FDA 483 - Annovex Pharma, Inc. - June 18, 2026

Between May 27 and June 3, 2026, the FDA conducted an inspection of Annovex Pharma, Inc., an outsourcing facility located in Lorton, Virginia. The resulting FDA 483 report details significant concerns regarding the firm"s ability to maintain sterile manufacturing conditions and provide adequate quality oversight. Key violations include the failure to maintain equipment used to control aseptic environments. Specifically, multiple laminar airflow hoods failed airflow velocity tests during certification, yet the firm failed to initiate an investigation or assess the impact on products already distributed, such as NAD+ injections. Additionally, the company failed to conduct mandatory annual reviews for several drug products, including Lorazepam and Phenylephrine Hydrochloride. The inspection noted that the internal procedures for these reviews remained in draft form and had never been approved by management. These observations were issued under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. Although the 483 form does not represent a final agency determination, Annovex Pharma is required to address these deficiencies. The company must implement corrective actions, such as performing product impact assessments and finalizing quality assurance protocols, to ensure all manufactured drugs meet safety and purity standards. The firm is encouraged to submit a formal response to the FDA outlining their plan for remediation.