Regulatory Focus™ > News Articles > Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Faciliti

Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities

Posted 05 February 2016 | By Zachary Brennan 

Health Canada Outlines 2016 Deficiencies at Actavis, Sanofi, Gilead and Other Manufacturing Facilities

As part of Health Canada’s transparency push, the regulator is unleashing new information about its work, including an updated good manufacturing practice (GMP) inspection database that reveals new GMP deficiencies for Actavis, Sanofi-Aventis, Gilead, Baxter and other manufacturing facilities from inspections conducted in January 2016.

Although none of the findings of the inspections have been listed on Health Canada’s inspection tracker, and specific details on the facilities have not been released, the inspection deficiencies offer a look into what the regulator has been focused on in recent inspections. 

Actavis

According to the inspection tracker, Actavis Pharma’s Mississauga, Ontario-based plant was inspected over almost two weeks early last month. Health Canada officials uncovered three deficiencies linked to quality control, the quality and completeness or availability of required records, and other issues with the “monitoring, routine testing or period of validity established for the stability of the drugs produced/handled by the establishment.”

This was the second inspection conducted at the plant’s site in the past three years, and Health Canada notes that this was a “regular” inspection, as opposed to an inspection conducted for a specific cause.

A separate site linked to the company’s specialty pharmaceuticals in Mississauga was also cited with three deficiencies after an inspection in mid-January that found quality control, records and stability issues. Actavis did not respond to a request for comment.

Sanofi-Aventis Canada

Sanofi’s manufacturing facility in Laval, Quebec, was also inspected by Health Canada officials in early January over the course of five days. Inspectors listed five deficiencies related to manufacturing control, quality control, finished product testing, recordkeeping and deficiencies in the production and/or handling of products intended to be sterile.

The inspection was the first that the site has seen since May 2012.

Catherine Cunningham, a Sanofi spokeswoman, told Focus: "Our report is one of the first ones going up, and our team received the info on this this morning and are digesting it. There was nothing that was of serious concern to public health."

Gilead Sciences

Gilead’s Mississauga-based manufacturing facility was inspected from 5 January to 6 January, and only two deficiencies were noted.

“Deficiencies were noted in the written procedures and/or control systems in place to ensure that the drugs produced or handled meet their specifications,” Health Canada said. The other deficiency was linked to the firm’s quality control department. This was the site’s first inspection since September 2014. Gilead did not respond to a request for comment.

Baxter

The company’s Alliston, Ontario-based site was inspected over 11 days by Health Canada, which uncovered four deficiencies linked to equipment, personnel, raw material testing and quality control. This was the site’s first inspection since October 2013.

Baxter spokesman John O'Malley told Focus: "The recent inspection of Baxter’s Aliston, ON, facility by Health Canada resulted in a rating of Compliant, and no significant issues were identified. Some of Health Canada’s observations were addressed and fixed before the inspection was even complete. Baxter values all actions that aid our efforts to continuously improve our operations and meet our mission of providing lifesaving and life-sustaining products to patients. That includes internal audits, external assessments and interaction and collaboration with health authorities." 

Others

Warner Chilcott Canada, Procter & Gamble, Dr. Reddy's Laboratories Canada, Apotex Pharmachem, Accupharma and Attix were also cited as receiving inspections in January 2016 with deficiencies cited.


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