France's ANSM raises GMP concerns at Brazilian aseptic plant

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Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.

An inspection of the Rio de Janeiro facility in February led to France’s Agence Nationale de Sécurité du Médicament (ANSM) issuing a statement of non-compliance with GMP citing seven critical deficiencies and seven major deficiencies, a version of which is embedded below.

The deficiencies centred on problems with aseptic production, with the first slamming the plant’s quality system and its “poor handling of deviations, poor handling of product quality reviews, and absence of risk management consideration in the quality manual.”

The ANSM also cited unsuitable operator behaviour, saying aseptic workers: “Joined hands, stand by crossed arms, arms touching the body at several occasions, rapid motions, no disinfection of gloves before entering hands in grade A, whole upper part of the body entering into grade A, no dedicated storage of the tool used to grab cartridges, and an operator used his grabbing tool again after it had dropped on the ground.”

The inspection came about after the firm – NOVA DFL industrie et commerce France – applied for marketing approval of its injectable adrenaline solution for dental use, Artiadre 40 mg/mL, with the French regulators last year.

The ANSM marked an inspection of the site as an action point in October, and after raising the deficiencies has refused the application request.

Refusal of the national marketing authorisation request of the product ARTIADRE® 100 40mg/ml 0,01 mg/ml, aseptically prepared sterile product,” the ANSM said in its report.

“According to the information provided by the site, no EU customer was identified for any medicinal product manufactured by the site. National competent authorities should evaluate the criticality of products being supplied by this manufacturing site and enact measures to ensure continued supplied where appropriate.”

 

ANSM NOVA DFL INDUSTRIE E COMMERCIO SA by Dan Stanton on Scribd

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