# FDA 483 - Bora Pharmaceuticals Injectables Inc - August 27, 2010

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/053d423a-ee3b-4474-95eb-e7981f3b1e37

> FDA 483 for Bora Pharmaceuticals Injectables Inc on August 27, 2010. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Inspection Date: 2010-08-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Cangene bioPharma Inc. in Baltimore, MD, revealed significant deficiencies in quality assurance, aseptic processing, and facility maintenance. The firm failed to thoroughly investigate product discrepancies, maintain adequate visual inspection programs, and ensure proper material segregation and preventative maintenance for critical systems. These issues indicate a lack of robust controls over manufacturing processes and product quality.

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## Related Officers

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- [Dale Miller](https://www.keypedia.com/people/dale-miller/9ad4ac9f-20a7-4464-b0de-05f55ac49552)

Company: https://www.keypedia.com/companies/bora-pharmaceuticals-injectables-inc/d6e15b21-41fb-4f18-9638-893d3f44fcd1

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e