Orthana Kemisk Fabrik A/S – FDA EIR, Sep 23, 2022

A for-cause inspection of Orthana Kemisk Fabrik A/S, a manufacturer of non-sterile active pharmaceutical ingredients (API), was conducted by the FDA from September 19-23, 2022. The inspection aimed to assess cGMP compliance for the production of Powder USP, guided by CP7356.002 and ICH Q7A. This was the initial inspection of the firm. During the inspection, an FDA Form 483 was issued, detailing several significant deficiencies. These included the failure to adequately conduct quality management and product review, the unauthorized provision of superuser rights to quality control laboratory employees, and the failure to properly investigate out-of-specification results. Furthermore, the firm was cited for invalidating data without scientific justification and utilizing equipment that was not qualified for API manufacturing. Additional concerns, such as inadequate monitoring of analytical columns, a leak in a specific room, and issues with equipment calibration and maintenance, were also discussed with management. Orthana Kemisk Fabrik A/S management acknowledged the observations, committing to assess the issues and implement corrective actions. A written response was promised within 15 business days. The inspection was classified as Voluntary Action Indicated (VAI), mandating a re-inspection in the future. The Center for Drug Evaluation and Research (CDER) will make the final decision regarding the product's classification.