TOURS, France – Indena, a leading company that develops and manufactures plant-derived active principles for use in health food, pharmaceuticals, and cosmetics, has announced that its production site in Tours has passed US FDA inspection. No FDA-483 was issued, as per EIR (Establishment Inspection Report) received from the Centre for Food Safety and Applied Nutrition of the FDA. This confirms the company’s compliance with new requirements mandated by the FDA Food Safety Modernization Act (FSMA).
The inspection covered the entire organisation, with particular attention to manufacturing operations, HACCP, hygiene, cleaning, recall, complaint and training programme and procedures.
“We are pleased with the successful outcome of the FDA inspection - said Fran?ois Mairel, Indena Tours plant director – the audit covered the manufacturing of important products we are selling to our US customer base, like grape seed, olive polyphenolic and ginkgo biloba extracts, and further confirms our commitment in giving our customers the highest standards of quality.”
The company has obtained the following certifications: GMP Certificate from the French Health Ministry – ANSM, HACCP, ISO 14001, Kosher, Halal certificate.
With more than 90 years of botanical experience, Indena focuses on the identification, development and production of active principles derived from plants. The company has more than 150 primary patents and has published more than 700 scientific studies. Headquartered in Milan, Indena has five production sites and four international branches throughout the world and manages sales in more than 70 countries. The company's experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMA, and ESCOP, and cooperate on the update of all the main pharmacopoeias.
Related link: US FDA Food Safety Modernization Act

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