# FDA 483 - Xylo Chem Industries - March 31, 2023

Source: https://www.globalkeysolutions.net/records/483/xylo-chem-industries/b9164b2c-d4c4-447b-89bd-7b334e9f8ffc

> FDA 483 for Xylo Chem Industries on March 31, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xylo Chem Industries
- Inspection Date: 2023-03-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.globalkeysolutions.net/companies/xylo-chem-industries/0e3954d1-a409-49ca-a234-a2b74500bea9

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1