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FDA Warning Letters – Significance and Implications

The scope of the regulatory responsibilities of the U.S. Food and Drug Administration is vast. Their mission is to protect the public health and they employ 16,914 civilians and 1,148 military, totaling 18,062. They are extremely “siloed” and slow to gain consensus on policy among their various internal groups. Their enforcement on the drug manufacturing sector stems from CFR 210 & 211, et seq., which constitutes “Current Good Manufacturing Practices,” abbreviated cGMP. The verbiage...
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