FDA 483 - Unilab Chemicals and Pharmaceuticals Private Ltd. - November 18, 2019

Unilab Chemicals and Pharmaceuticals Pvt. Ltd. in Dombivli, India, was inspected by the FDA from November 18-22, 2019, and received seven observations. The inspection revealed significant deficiencies in quality management, laboratory controls, materials management, and process equipment. Key issues included inadequate record-keeping, unapproved master production instructions, failure to investigate customer complaints, insufficient stability data, unsound sampling plans, unsuitable water for API manufacturing, and ineffective equipment cleaning.