FDA 483 - Xylo Chem Industries - March 31, 2023

Xylo Chem Industries, an Active Pharmaceutical Ingredient (API) manufacturer in Nadiad, Gujarat, India, received a Form 483 with ten significant observations. The inspection revealed widespread failures in fundamental quality control, including process and cleaning validation, equipment qualification, material handling, and record-keeping. These deficiencies indicate a severe lack of adherence to Good Manufacturing Practices, potentially compromising the quality and purity of their distributed API products.