# FDA 483 - Bora Pharmaceuticals Injectables Inc - April 16, 2021

Source: https://www.keypedia.com/records/483/bora-pharmaceuticals-injectables-inc/3983164b-34ae-45bc-8080-e729d3f55d6b

> FDA 483 for Bora Pharmaceuticals Injectables Inc on April 16, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bora Pharmaceuticals Injectables Inc
- Inspection Date: 2021-04-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Cangene BioPharma LLC, a pharmaceutical manufacturer in Baltimore, MD, was cited for four observations during an FDA inspection. The findings include failures in thoroughly reviewing batch failures, rejecting non-conforming components, maintaining aseptic technique during sterile drug product manufacturing, and keeping adequate equipment logs. These issues indicate significant concerns regarding quality control and sterile processing practices.

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## Related Officers

- [Derek Smith](https://www.keypedia.com/people/derek-smith/711ac1cb-9ddd-487d-b124-7c3ce6e755a4)
- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)
- [Kathleen M. Jordan](https://www.keypedia.com/people/kathleen-m-jordan/e08b786a-47bf-4e78-ae96-9d94cdc20bdb)

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