# FDA 483 - Bora Pharmaceuticals Injectables Inc - July 22, 2011

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/638f9e54-29a8-4fbb-8aa8-fd6f3a361675

> FDA 483 for Bora Pharmaceuticals Injectables Inc on July 22, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Inspection Date: 2011-07-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Cangene bioPharma, Inc. in Baltimore, MD, was inspected by the FDA from July 18-22, 2011, and received a Form 483 with four observations. The inspection revealed significant issues related to inadequate equipment cleaning procedures, inappropriate equipment design, failure to follow aseptic processing procedures, and ineffective employee training, indicating a moderate level of non-compliance.

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## Related Officers

- [Senior Advisor](https://www.keypedia.com/people/rachel-c-harrington/254a4217-8cd8-4a79-bf24-9345d34d0550)
- [William A. Warnick](https://www.keypedia.com/people/william-a-warnick/410a67e8-71fd-490b-9cc5-3eeebbf5363a)
- [Ernest P. Birjak](https://www.keypedia.com/people/ernest-p-birjak/5a5fab6c-c7c3-4a02-aefb-479f3893b362)
- [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