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"Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess." FDA Warning Letter, 2025 An out-of-specification result is not a problem in itself

herein, we refer to OI and NIO as populations. The study was conducted in accordance with principles and requirements of the International Council for Harmonization Good Clinical Practice guidelines and the principles of the Declaration of Helsinki