Xylo Chem Industries – FDA 483, Mar 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.
ID · b9164b2c-d4c4-447b-89bd-7b334e9f8ffc
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