United States v. Undetermined Quantities of Various Articles of Device Consisting in Whole or in Part of Proplast II or Proplast HA

How courts have described this case

Verbatim parenthetical descriptions written by other courts when citing this decision. Ranked by citation-network relevance.

• “[W]hether a manufacturer is, in the Court’s estimation, in substantial compliance with [C]GMP regulations is immaterial if the FDA, in its discretion, determines that full compliance with the regulations is necessary.”
• “In order to prove a claim of adulteration of a device based upon noncompliance with [C]GMP regulations, the Government need not establish that the device is actually deficient as a result of the [C]GMP violation.”

Source: CourtListener parenthetical corpus (CC0).