# FDA 483 - Bhargava Phytolab Private Limited - July 26, 2024

Source: https://www.globalkeysolutions.net/records/483/bhargava-phytolab-private-limited/2969bed9-911e-43c0-9b63-5954a8caa827

> FDA 483 for Bhargava Phytolab Private Limited on July 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bhargava Phytolab Private Limited
- Inspection Date: 2024-07-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Bhargava Phytolab Private Limited in Bhiwadi, India, a drug manufacturer, revealing significant deficiencies across multiple systems. The inspection cited inadequate component testing, poor facility maintenance, unvalidated cleaning processes, and failures in quality control, record-keeping, and deviation investigations. These issues indicate a lack of robust controls to ensure drug product quality, purity, and identity.

## Related Documents

- [WARNING_LETTER - 2024-07-26](https://www.globalkeysolutions.net/records/warning_letter/bhargava-phytolab-private-limited/4623b10e-0a63-4c01-bd5b-b1252bfd913e)

## Related Officers

- [Regulatory Affairs Specialist](https://www.globalkeysolutions.net/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.globalkeysolutions.net/companies/bhargava-phytolab-private-limited/feaad9ba-76ba-4be6-bc33-70ae6fb31c48

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