FDA 483 - Novel Laboratories, Inc. d.b.a Lupin Somerset - April 17, 2026

Novel Laboratories, Inc., doing business as Lupin Somerset, underwent an FDA inspection at its Somerset, New Jersey facility from April 13 to April 17, 2026. The inspection identified three primary areas of concern regarding the company"s adherence to safety and quality standards for drug manufacturing. First, the company failed to thoroughly investigate failed test results for raw materials. When a specific ingredient was found to degrade over time, the firm did not sufficiently assess how this degradation might impact the quality or shelf life of finished products already distributed to the market. Second, the facility’s methods for sampling high-risk ingredients lacked scientific justification. The company failed to provide a logical basis for the amount of material sampled and did not individually test every container for identity and purity, which is necessary to ensure consistent quality. Finally, the Quality Control department failed to follow its own internal protocols. Laboratory staff used over 20 unvalidated Excel spreadsheets for critical drug calculations. These files lacked necessary security features such as version control, tracking logs for changes, and formal management approval. Additionally, there was no evidence that these calculations were double-checked by a second reviewer. These observations were recorded under the Federal Food, Drug, and Cosmetic Act. While this report does not represent a final legal determination by the FDA, the company is required to respond to these findings. They must provide a detailed plan for corrective actions or submit objections to the observations to ensure future compliance with federal safety regulations.