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doi: 10.1007/s11356-013-2281-x 78 AmaralARamalho-SantosJSt JohnJC

Yosefzon, Y., Soteriou, D., Feldman, A., Kostic, L., Koren, E., Brown, S., Ankawa, R., Sedov, E., Glaser, F., & Fuchs, Y

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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