Zen Chemicals Private Limited – FDA EIR, Mar 28, 2023

An FDA Good Manufacturing Practice (GMP) inspection was conducted at Zen Chemicals Private Limited from March 23 to March 28, 2023. This pre-announced inspection focused on the manufacturing of non-sterile Active Pharmaceutical Ingredient (API) critical intermediate products, carried out under compliance program CPGM 7356.002F for Active Pharmaceutical Ingredient Process Inspections.The inspection concluded with the issuance of a five-item Form FDA 483, detailing significant observations. Key issues identified included inadequate cleaning and sanitation of equipment, a lack of thorough investigations into the root causes of multiple sample results, and insufficient controls for computer-acquired data and laboratory control system access. Additionally, the firm failed to qualify equipment and provide appropriate training to employees on cleaning procedures.Zen Chemicals management acknowledged these observations, committed to implementing corrective actions, and agreed to submit a written response within fifteen working days. Despite the findings, the inspection outcome was classified as "Voluntary Action Indicated" (VAI) for GMP coverage. This classification was due to the inspected product being an API intermediate, considered low risk because it will undergo further manufacturing steps, mitigating immediate concerns. The company’s annual registration is current, and no samples were collected or refusals encountered during the inspection.