# FDA 483 - Indiana Chem-Port - August 07, 2021

Source: https://www.globalkeysolutions.net/records/483/indiana-chem-port/aeb60a25-30de-4716-bbf7-1850288b9ee6

> FDA 483 for Indiana Chem-Port on August 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indiana Chem-Port
- Inspection Date: 2021-08-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Indiana Chem-Port, an Active Pharmaceutical Ingredient manufacturer in Vadodara, India, was inspected by the FDA from August 2-7, 2021. The inspection revealed significant deficiencies across its manufacturing and quality control operations, including a lack of process validation, inadequate quality unit oversight, and poor data integrity controls. These issues indicate a systemic failure to ensure product quality and purity.

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/indiana-chem-port/9fccfdc3-9a1c-478f-a9aa-4c9fd4c043c2

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