21 C.F.R. § 111.25
What are the requirements under this subpart D for written procedures?
You must establish and follow written procedures for fulfilling the requirements of this subpart D, including written procedures for:
(a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement;
(b) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and
(c) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
Notes of Decisions
Cited in 2
cases, 2011–2011 · leading case: All. for Nat. Health U.S. v. Sebelius, 775 F. Supp. 2d 114 (D.D.C. 2011).
All. for Nat. Health U.S. v. Sebelius, 775 F. Supp. 2d 114 (D.D.C. 2011). “” 2 For example, 21 C.F.R. § 111.25 , which the plaintiffs object to, requires a manufacturer to “establish and follow written procedures” for, inter alia, “[cjalibrating instruments and controls [used] in manufacturing or testing a component or dietary supplement .”
All. for Nat. Health US v. Sebelius, No. 2009-1523 (D.D.C. Apr. 6, 2011). “”2 For example, 21 C.F.R. § 111.25 , which the plaintiffs object to, requires a manufacturer to “establish and follow written procedures” for, inter alia, “[c]alibrating instruments and controls [used] in manufacturing or testing a component or dietary supplement… [and]…”
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