C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart D—Equipment

21 C.F.R. § 211.63

Equipment design, size, and location

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Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

Notes of Decisions
Cited in 3 cases (1 in the last 5 years), 2011–2026 · leading case: All. for Nat. Health U.S. v. Sebelius, 775 F. Supp. 2d 114 (D.D.C. 2011).
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All. for Nat. Health U.S. v. Sebelius, 775 F. Supp. 2d 114 (D.D.C. 2011). “") (food); 21 C.F.R. § 211.63 ("Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.”
Shareholder Rep. Servs., LLC v. Alexion Pharm., Inc. (Del. Ch. 2026). · cites it 3× “”) with 21 C.F.R § 211.63 (“Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.”
All. for Nat. Health US v. Sebelius (D.D.C. 2011). “”) (food); 21 C.F.R § 211.63 (“Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.”
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