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351(a)(1)] and that your compounded and manufactured sterile drug products are adulterated within the meaning of Section 501(a)(2)(A) of the Act [21 U.S.C

While Pure Indulgence responded to FDA's Form 483 before the warning letter was issued, stating that it was taking corrective actions, the agency said it was insufficient because the response lacked sufficient details and documentation

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Initial structure of FXIIIa was prepared by removing the crystallographic water molecules and adding hydrogen atoms consistent with the physiologic pH of 7 using Maestro 12.4.1 Then, the protein molecule was energy minimized with an RMSD cutoff value of 0.3 for all heavy atoms