# FDA 483 - Bora Pharmaceuticals Injectables Inc - February 18, 2022

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/e6339f64-825d-46ba-8a57-c60db4c4a441

> FDA 483 for Bora Pharmaceuticals Injectables Inc on February 18, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Inspection Date: 2022-02-18
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Cangene BioPharma LLC in Baltimore, MD, a drug product manufacturer, was cited for multiple deficiencies during an FDA inspection. Issues included inadequate recertification of HEPA filters in aseptic processing areas, a significant backlog of overdue deviations without proper extensions or severity classifications, and insufficient procedures for maintaining equipment and documenting disinfectant contact times. Additionally, the firm failed to follow proper aseptic techniques and lacked an adequate rejection rate for visually inspected incoming glass vials.

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## Related Officers

- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

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

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64