# FDA 483 - Halo Pharmaceutical Canada Inc - November 14, 2014

Source: https://www.globalkeysolutions.net/records/483/halo-pharmaceutical-canada-inc/a4ed44d4-b5fe-4334-8564-aaf9310152b1

> FDA 483 for Halo Pharmaceutical Canada Inc on November 14, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Halo Pharmaceutical Canada Inc
- Inspection Date: 2014-11-14
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Halo Pharmaceutical Canada Inc. in Mirabel, Quebec, a contract drug manufacturer, was cited for multiple deficiencies during an FDA inspection from November 10-14, 2014. Key issues included inadequate laboratory controls for test procedures, incomplete out-of-specification investigations, and failures in labeling inspection, change control, and material storage procedures. These observations indicate significant concerns with quality control and adherence to established procedures.

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## Related Officers

- [ Assistant Country Director (USFDA India Office Drug Program)](https://www.globalkeysolutions.net/people/daniel-j-roberts/1e1836ac-8bca-4236-a267-33ee0456440c)

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

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