FDA 483 - Shilpa Medicare Limited - November 10, 2025

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 10 to November 21, 2025, at Shilpa Medicare Limited in Polepally, Telangana, India, a drug product manufacturer, significant deficiencies were observed regarding the validation of aseptic and sterilization processes. The primary concern was the inadequacy of procedures designed to prevent microbiological contamination in sterile drug products.

Specifically, the FDA noted that the company"s qualification of airflow in critical manufacturing areas was insufficient. Smoke studies, intended to evaluate unidirectional airflow and contamination risk, utilized a smoke type that was not neutrally buoyant. This methodological flaw could potentially obscure actual airflow patterns, making it difficult to identify critical issues such as recirculating air or dead spots. Investigators also observed turbulence during various critical aseptic operations. Furthermore, the smoke studies were deemed incomplete, as they did not represent all routine production activities. This included the undocumented removal of essential equipment during studies and the omission of demonstrations for sterile equipment dissemination, placement of tools, and certain environmental monitoring activities. Several specific "fallen vial" interventions were also not performed during the studies, despite being grouped by common intervention names.

These observations highlight a critical need for Shilpa Medicare Limited to implement robust corrective actions to ensure proper validation of their aseptic processes. Adherence to stringent manufacturing standards is essential to guarantee the sterility and safety of their drug products, aligning with regulatory expectations for drug product manufacturers.