# FDA 483 - Bora Pharmaceuticals Injectables Inc - August 01, 2012

Source: https://www.globalkeysolutions.net/records/483/bora-pharmaceuticals-injectables-inc/7cd75684-6adc-40ee-8339-d3d53b9fca82

> FDA 483 for Bora Pharmaceuticals Injectables Inc on August 01, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Inspection Date: 2012-08-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Cangene bioPharma, Inc. in Baltimore, MD, a drug manufacturer, revealed a significant observation regarding deviations from written production and process control procedures. The firm failed to adequately justify additional mixing times, proceed with filling despite out-of-specification protein concentration results without root cause, and use drug substance with black specks without proper risk assessment documentation. These issues indicate a lack of documented justification for critical manufacturing decisions and product release.

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## Related Officers

- [Senior Advisor](https://www.globalkeysolutions.net/people/rachel-c-harrington/254a4217-8cd8-4a79-bf24-9345d34d0550)

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

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