# FDA 483 - Ramdev Chemical Private Limited - December 05, 2025

Source: https://www.globalkeysolutions.net/records/483/ramdev-chemical-private-limited/9632d789-0267-4397-9de4-e33a20f70bfc

> FDA 483 for Ramdev Chemical Private Limited on December 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ramdev Chemical Private Limited
- Inspection Date: 2025-12-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Ipca Laboratories Limited in Palghar, Maharashtra, India, an API manufacturer, revealed significant deficiencies across three observations. These included inadequate facility maintenance leading to potential contamination, deficient analytical method verification studies for API testing, and a lack of controls to prevent carryover of residual materials between manufacturing batches. The findings indicate a need for improved quality systems and manufacturing controls to ensure product quality for the US market.

## Related Officers

- [Saleem A. Akhtar](https://www.globalkeysolutions.net/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.globalkeysolutions.net/companies/ramdev-chemical-private-limited/76911e09-d683-4884-b7ad-ac1f588687ce

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8