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Enhanced sampling: Implemented late Initially limited to one supplier Not justified with defined protocols, sample size rationale, or tightened acceptance criteria Re-inspection of finished product: Proposed but not supported by documented procedures or defined AQL controls FDA treated these issues collectively as a failure to prevent microbiological and particulate contamination , not as isolated supplier or inspection gaps

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Pineal melatonin is synthesized in the absence of light (typically at night) under sympathetic control