FDA 483 - Neeyaan LLC - January 27, 2026

From January 13 to January 27, 2026, the FDA conducted an inspection of the Neeyaan LLC manufacturing facility in Cranbury, New Jersey. The investigators identified 25 distinct observations regarding the production of over-the-counter (OTC) drug products and dietary supplements. The primary violations center on a significant lack of oversight by the Quality Control unit. Specifically, the firm distributed products before final testing results were approved and failed to investigate manufacturing deviations, such as tablet breakage and equipment issues. There was a widespread absence of scientific data to support product quality; the company had not conducted stability testing to justify expiration dates, nor had they validated their manufacturing processes or laboratory testing methods. Documentation practices were found to be severely deficient, with batch records often missing raw material lot numbers, yield calculations, and required independent verifications. Additionally, the facility failed to maintain equipment and storage areas properly, evidenced by damaged HEPA filters in production rooms and a lack of continuous temperature monitoring for sensitive materials. These observations are issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act to ensure manufacturing standards are met. Although this report does not represent a final agency decision, Neeyaan LLC is expected to respond to the FDA. The company should submit a written plan detailing their corrective actions or providing explanations for any disputed findings to address these critical safety and quality concerns.