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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

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The word rationing tells us what is really going on here Even if treatment for such conditions was given “ideally” the saving would be roughly only 18 hours per nurse a year