Home / CFR sections / 21 CFR 820.30(g)

21 CFR 820.30(g) citations

Design validation - user needs and intended uses

FDA investigators cited 21 CFR 820.30(g) 1,961 times at 1,377 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 16, 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
202632
202598
202475
202364
202269
202131
202045
2019112
2018125
2017126

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 16, 2026DASISIMULATIONS, LLCUnited StatesRisk analysis is inadequate and is incomplete.
Jan 15, 2026Expanse Medical Inc.United StatesProcedures for design validation have not been adequately established.
Jan 13, 2026Nuclein LLCUnited StatesRisk analysis is inadequate.
Jan 12, 2026Innova Vascular IncUnited StatesRisk analysis is inadequate.
Jan 12, 2026ZIIP INCUnited StatesProcedures for design validation have not been adequately established.
Jan 12, 2026ZIIP INCUnited StatesRisk analysis is inadequate.
Dec 19, 2025Excel Medical Electronics LLCUnited StatesRisk analysis is inadequate.
Dec 12, 2025Black Diamond Video Inc.United StatesRisk analysis is inadequate.
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesRisk analysis is inadequate.
Dec 10, 20253B Medical, Inc.United StatesRisk analysis is inadequate and is incomplete.
Dec 4, 2025Unetixs Vascular, Inc.United StatesRisk analysis is incomplete.
Dec 3, 2025BTI FiltrationUnited StatesRisk analysis was not performed.
Dec 2, 2025OnePacs, LLCUnited StatesProcedures for design validation have not been adequately established.
Dec 1, 2025Focalyx Technologies, LLC.United StatesDesign validation did not ensure the device conforms to defined user needs and intended uses.
Nov 21, 2025Olympus Medical Systems CorporationJapanRisk analysis is incomplete.
Nov 21, 2025Olympus Winter & IBE GmbhGermanyDesign validation did not ensure the device conforms to defined user needs and intended uses.
Nov 20, 2025Reprise Biomedical, Inc.United StatesRisk analysis is inadequate.
Nov 14, 2025Shirakawa Olympus Co., Ltd.JapanRisk analysis is incomplete.
Nov 13, 2025Span Medical Products Canada D/B/A M.C. Healthcare ProductsCanadaThe results of design validation, including identification of the design, method(s), the date and the individual(s) performing validation, were not documented in the design history file.
Nov 7, 2025AOMORI OLYMPUS CO., LTD. Kuroishi SiteJapanRisk analysis is incomplete.
Nov 7, 2025Kerber USA Inc.United StatesThe results of design validation, including identification of the design, method(s), the date and the individual(s) performing validation, were not documented in the design history file.
Nov 5, 2025Intuitive Surgical, Inc.United StatesRisk analysis is inadequate.
Oct 28, 2025Criticare Technologies, Inc.United StatesResults of the design risk analysis were not adequately documented.
Oct 28, 2025Criticare Technologies, Inc.United StatesProcedures for design validation have not been adequately established.
Oct 27, 2025RG Medical USAUnited StatesProcedures for design validation have not been adequately established.

Search more

Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

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