# FDA 483 - SHREEPATI PHARMACEUTICALS PRIVATE LIMITED - December 02, 2023

Source: https://www.globalkeysolutions.net/records/483/shreepati-pharmaceuticals-private-limited/a213dc5b-0bf4-4176-8798-f9912fac4fd6

> FDA 483 for SHREEPATI PHARMACEUTICALS PRIVATE LIMITED on December 02, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SHREEPATI PHARMACEUTICALS PRIVATE LIMITED
- Inspection Date: 2023-12-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shreepati Pharmaceuticals Private Ltd. in Dhar District, Madhya Pradesh, India, an intermediate manufacturer, revealed significant deficiencies. Observations included contaminated manufacturing equipment, lack of stability data for intermediates, failure to retain essential records and reserve samples, and inadequate demonstration of water system suitability. These issues highlight serious concerns regarding the firm's quality control and manufacturing processes.

## Related Officers

- [Rose L. Jean-Mary](https://www.globalkeysolutions.net/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)

Company: https://www.globalkeysolutions.net/companies/shreepati-pharmaceuticals-private-limited/eb2a28f0-9ab9-4370-833d-4e17e10f73bb

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