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21 CFR 820.30(c) citations

Incomplete, ambiguous, conflicting design requirements

FDA investigators cited 21 CFR 820.30(c) 339 times at 313 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 22, 2025. 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
20263
202516
202411
202311
20229
202110
202011
201918
201814
201718

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 22, 2025Ashland Specialty Ingredients, G.P.United StatesProcedures for design input have not been adequately established.
Nov 21, 2025Olympus Winter & IBE GmbhGermanyProcedures for design input have not been adequately established.
Nov 18, 2025S4 Medical CorpUnited StatesDesign input requirements were not adequately documented.
Aug 27, 2025Exactech, Inc.United StatesDesign input requirements were not adequately documented.
Aug 13, 2025Medical Instrument Development Laboratories, Inc.United StatesProcedures for design input have not been adequately established.
Aug 8, 2025Fresenius Kabi USA, LLCUnited StatesProcedures for design input have not been adequately established.
Jul 30, 2025OxiWear Inc.United StatesDesign input requirements were not adequately documented.
May 16, 2025Blue Elephant IncUnited StatesDesign input requirements were not adequately documented.
May 8, 2025HAPPE SPINE, LLC.United StatesDesign input requirements were not adequately documented.
May 7, 2025Surgtech IncUnited StatesDesign input requirements were not adequately documented.
May 1, 2025INSUNG MEDICAL CO LTDKorea (the Republic of)Design input requirements were not adequately documented.
Apr 23, 2025Miach OrthopaedicsUnited StatesProcedures for design input have not been adequately established.
Apr 10, 2025Vonco Products, LLCUnited StatesProcedures for design input have not been adequately established.
Feb 7, 2025Lazurite Inc.United StatesDesign input requirements were not adequately documented.
Feb 5, 2025NeuroSync, Inc.United StatesProcedures for design input have not been adequately established.
Jan 24, 2025Microlight Corporation Of AmericaUnited StatesDesign input requirements were not documented.
Nov 19, 2024JB Medical Development LLCUnited StatesDesign input requirements were not documented.
Nov 14, 2024Cantor & Barnard Ltd.United KingdomDesign input requirements were not adequately documented.
Nov 7, 2024Dexcom, Inc.United StatesProcedures for design input have not been adequately established.
Aug 8, 2024Qapel Medical Inc.United StatesDesign input requirements were not adequately documented.
Jul 11, 2024Future Diagnostics Solutions B.V.NetherlandsDesign input requirements were not adequately documented.
Jun 5, 2024Empyrean Medical Systems IncUnited StatesDesign input requirements were not documented.
May 9, 2024Viscus Biologics LLCUnited StatesDesign input requirements were not adequately documented.
Feb 1, 2024Cardio Medical ProductsUnited StatesProcedures for design input have not been adequately established.
Jan 10, 2024JSM SOLUTIONS LLCUnited StatesDesign input requirements were not adequately documented.

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