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Some 503B Warning letters involved mislabeling where the compounded product did not bear the label ‘this is a compounded drug’ or ‘this is a repackaged drug.’ Others pertained to inadequate Policies & Procedures (P&P) for the Quality Control units
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A comparison should identify the species or cell system, tissue or cell population, experimental condition, sampling interval, assay, and normalization method
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If the policy is unavailable, ask for it rather than filling the gap with expectations. Make the purchase with a clear understanding of the applicable process rather than a presumed universal refund policy.
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