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21 CFR 820.30(i) citations

Design changes - validation vs. verification

FDA investigators cited 21 CFR 820.30(i) 1,001 times at 863 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 12, 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
202611
202543
202436
202342
202242
202112
202024
201946
201872
201770

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 12, 2026ZIIP INCUnited StatesProcedures for design change have not been adequately established.
Jan 7, 2026Osseofuse International Inc.United StatesProcedures for design change have not been established.
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesProcedures for design change have not been adequately established.
Dec 10, 2025Next Medical Products Company, LLCUnited StatesProcedures for design change have not been adequately established.
Dec 4, 2025Unetixs Vascular, Inc.United StatesProcedures for design change have not been adequately established.
Nov 18, 2025Swan Valley Medical, IncorporatedUnited StatesProcedures for design change have not been adequately established.
Nov 7, 2025Kerber USA Inc.United StatesProcedures for design change have not been established.
Nov 6, 2025Akervall Technologies, Inc.United StatesProcedures for design change have not been adequately established.
Oct 27, 2025RG Medical USAUnited StatesProcedures for design change have not been adequately established.
Oct 20, 2025McLaren FlintUnited StatesProcedures for design change have not been adequately established.
Oct 16, 2025Silq Technologies CorporationUnited StatesProcedures for design change have not been adequately established.
Aug 19, 2025Diasol, IncUnited StatesProcedures for design change have not been adequately established.
Aug 8, 2025Fresenius Kabi USA, LLCUnited StatesProcedures for design change have not been adequately established.
Aug 7, 2025Hong Qiangxing (Shen Zhen) Electronics LimitedChinaProcedures for design change have not been adequately established.
Jul 30, 2025Wexler Surgical, Inc.United StatesProcedures for design change have not been adequately established.
Jul 25, 2025Happiest Baby, IncUnited StatesProcedures for design change have not been adequately established.
Jul 25, 2025Pacific Consolidated Industries LLCUnited StatesProcedures for design change have not been adequately established.
Jun 27, 2025Medspira, LLCUnited StatesProcedures for design change have not been adequately established.
Jun 27, 2025NIMBLEHEART, INCUnited StatesProcedures for design change have not been adequately established.
Jun 26, 2025Pointcore Supply Chain Service LLCUnited StatesProcedures for design change have not been established.
Jun 18, 2025Radiology Information Systems, Inc.United StatesProcedures for design change have not been adequately established.
Jun 13, 2025Ion Medical, Inc.United StatesProcedures for design change have not been established.
Jun 12, 2025Forward Science Technologies LLCUnited StatesProcedures for design change have not been adequately established.
May 30, 2025Thoratec LLCUnited StatesProcedures for design change have not been adequately established.
May 28, 2025BRAIN SCIENCE TOOLS BVNetherlandsProcedures for design change have not been adequately established.

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