# FDA 483 - Bora Pharmaceutical Services Inc. - January 28, 2025

Source: https://www.globalkeysolutions.net/records/483/bora-pharmaceutical-services-inc/ce4a122b-fd61-4713-b542-7d6e10c253fe

> FDA 483 for Bora Pharmaceutical Services Inc. on January 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceutical Services Inc.
- Inspection Date: 2025-01-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Bora Pharmaceutical Services Inc., a contract manufacturer of human drug products in Mississauga, was cited for nine observations during an FDA inspection. The inspection revealed significant deficiencies across quality control, laboratory operations, stability testing, and batch record management. Key issues include inadequate analytical testing for product release, insufficient review of production records, non-compliance with stability protocols, incomplete instrument qualifications, and poor control over labeling materials.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Miguel A. Martinez](https://www.globalkeysolutions.net/people/miguel-a-martinez/62e722b2-30bd-4671-9db9-8f089093e5a5)

Company: https://www.globalkeysolutions.net/companies/bora-pharmaceutical-services-inc/08721aae-68f2-48e1-9567-1bdae461c5d7

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