# FDA 483 - Bora Pharmaceuticals Injectables Inc - April 09, 2014

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/b405fd36-830c-4638-831a-f978c0f67a51

> FDA 483 for Bora Pharmaceuticals Injectables Inc on April 09, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Inspection Date: 2014-04-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Cangene bioPharma, Inc. dba Emergent BioSolutions in Baltimore, MD, was cited for inadequate process performance qualification and validation for its HP Acthar Gel. The inspection revealed a lack of written procedures for production and process controls, specifically concerning batch size increases and associated documentation. This indicates significant deficiencies in ensuring drug product quality and purity.

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- [483 - 2016-12-20](https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/a7effc90-b156-4479-9eb5-030aaa9c8c96)

## Related Officers

- [investigator](https://www.keypedia.com/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)
- [Brooke K. Higgins](https://www.keypedia.com/people/brooke-k-higgins/d3d34a14-68db-4233-bc1f-876895cd211b)

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