# FDA 483 - BDR Pharmaceuticals International Private Ltd. - November 20, 2025

Source: https://www.globalkeysolutions.net/records/483/bdr-pharmaceuticals-international-private-ltd/6cdffd55-08cd-4775-a65a-968c17145c82

> FDA 483 for BDR Pharmaceuticals International Private Ltd. on November 20, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BDR Pharmaceuticals International Private Ltd.
- Inspection Date: 2025-11-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: BDR Pharmaceuticals International Private, Ltd. in Halol, India, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate procedures to prevent microbiological contamination, insufficient laboratory controls for personnel monitoring and sample integrity, and poor maintenance of equipment and facility design in aseptic processing areas. These issues collectively indicate a lack of control over the sterile manufacturing environment and processes.

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/bdr-pharmaceuticals-international-private-ltd/d36e117e-71a4-4656-8247-f14403e4bdd8

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