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21 CFR 211.63 citations

Equipment Design, Size and Location

FDA investigators cited 21 CFR 211.63 698 times at 584 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 31, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
202629
202568
202471
202347
202243
202118
202031
201945
201839
201732

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
Jul 31, 2026Episciences IncUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Jul 20, 2026Biochemical And Scientific Consultants CcSouth AfricaEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Jun 26, 2026Advanced Cosmetic Research Laboratories, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Jun 5, 2026My CHS Rx, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
May 22, 2026I 3 PHARMACEUTICALS, LLCUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
May 15, 2026Emcure Pharmaceuticals LimitedIndiaEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
May 13, 2026Advagen Holdings, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
May 8, 2026Sombra Cosmetics, IncUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
May 7, 2026Topical Pharmaceuticals, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Apr 21, 2026Ajanta Pharma Ltd.IndiaEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size to facilitate operations for its intended use.
Apr 6, 2026Nova Biologicals, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Apr 2, 2026Baxter Healthcare CorporationUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Mar 20, 2026Eosera, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Mar 10, 2026Cosmetic Lab, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Mar 6, 2026Saptalis Pharmaceuticals LLCUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use and cleaning and…
Feb 13, 2026K.C. Pharmaceuticals, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Feb 6, 2026Alcami Carolinas CorporationUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Feb 3, 2026MEGHMANI LLPIndiaEquipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use.
Dec 22, 2025Blaine Labs IncUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Dec 19, 2025FillTech USA, LLCUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Dec 11, 2025Denver Solutions, LLCUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Nov 21, 2025Unipharm Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Nov 19, 2025Vintage Chemical, Inc.United StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Nov 6, 2025Lloyd Inc. Of IowaUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Nov 4, 2025Geneva Laboratories, IncUnited StatesEquipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.