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Brief
The inspection at Rolylab's facility in L'Etrat, Loire, revealed significant non-conformities and deficiencies. A letter was sent to the company on July 17, 2024, outlining these issues, which included management of deviations, training, material storage, water purification, document management, equipment qualification, material control, packaging operations, and supplier management. The French National Agency for Medicines and Health Products Safety (ANSM) issued a formal notice to Rolylab, requiring the company to correct various deficiencies within specific timeframes. The company must implement measures to ensure good storage conditions for materials, complete document management, and qualify equipment, among other requirements.
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