# FDA 483 - Bora Pharmaceuticals Injectables Inc - Unknown Date

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/356911f2-117b-44f4-a196-a5fadcd6a699

> FDA 483 for Bora Pharmaceuticals Injectables Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: Cangene BioPharma in Baltimore, MD, received a Form 483 following a Pre-Approval Inspection. The inspection revealed significant deficiencies in process validation, including failed batches and inadequate testing. Additionally, the firm lacked sufficient controls to prevent cross-contamination and demonstrated insufficient cleaning verification for product contact equipment.

## Related Documents

- [483 - 2011-07-22](https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/638f9e54-29a8-4fbb-8aa8-fd6f3a361675)
- [483 - 2014-08-26](https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/7700f152-efc1-48b2-9523-7c6ce5bf325f)
- [483 - Unknown Date](https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/06164505-9f08-47b4-9ba5-ba2bcb211dfa)
- [483 - 2016-12-20](https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/a7effc90-b156-4479-9eb5-030aaa9c8c96)
- [483 - 2014-04-09](https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/b405fd36-830c-4638-831a-f978c0f67a51)

## Related Officers

- [Nicole Trudel](https://www.keypedia.com/people/nicole-trudel/4c055b9a-84d1-4395-a4a7-b7c922e20669)
- [Michael Vardon](https://www.keypedia.com/people/michael-vardon/89a57fd7-96e5-4f60-843c-464dcfea6e40)
- [Quyen Tran](https://www.keypedia.com/people/quyen-tran/ae1979aa-97e9-4b3d-a1ac-1c89baae3b65)

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

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4