# FDA 483 - Bora Pharmaceuticals Injectables Inc - August 10, 2023

Source: https://www.globalkeysolutions.net/records/483/bora-pharmaceuticals-injectables-inc/9d83f300-05f9-4ed9-b3f5-038dafd18e22

> FDA 483 for Bora Pharmaceuticals Injectables Inc on August 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Inspection Date: 2023-08-10
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Cangene BioPharma, LLC in Baltimore, MD, a drug product manufacturer, was inspected from July 31 to August 10, 2023, and received a Form FDA 483 with four observations. The observations highlight significant deficiencies in contamination control, quality unit procedures, aseptic process validation, and equipment qualification, indicating a lack of robust controls for sterile drug product manufacturing. These issues collectively suggest a moderate to severe risk to product quality and patient safety.

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## Related Officers

- [Annet R. Rajan](https://www.globalkeysolutions.net/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)
- [Investigator](https://www.globalkeysolutions.net/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

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

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