# FDA 483 - Halo Pharmaceutical Canada Inc - September 28, 2023

Source: https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-canada-inc/da2c8c47-a0ad-42fb-9779-22cebc86c386

> FDA 483 for Halo Pharmaceutical Canada Inc on September 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Halo Pharmaceutical Canada Inc
- Inspection Date: 2023-09-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Halo Pharmaceutical Canada Inc, a contract drug manufacturer in Mirabel, Quebec, revealed significant deficiencies in quality control and manufacturing processes. Observations included failures to thoroughly investigate out-of-specification results for drug product impurities, incomplete cleaning validations for manufacturing equipment, and inadequately qualified production equipment. These issues indicate a lack of robust control over critical aspects of drug product manufacturing.

## Related Documents

- [483 - 2014-11-14](https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-canada-inc/a4ed44d4-b5fe-4334-8564-aaf9310152b1)

## Related Officers

- [Kenneth H. Williams](https://www.globalkeysolutions.net/people/kenneth-h-williams/20a225cd-a3d5-478f-ae04-2a8e119df8a6)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.globalkeysolutions.net/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.globalkeysolutions.net/companies/halo-pharmaceutical-canada-inc/1f4cfadf-e895-4fd7-a813-959f505dd7ce

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1