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21 CFR 820.30(f) citations

Design verification - unresolved discrepancies

FDA investigators cited 21 CFR 820.30(f) 648 times at 567 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
202610
202520
202422
202320
202218
20216
202018
201929
201831
201747

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 12, 2026ZIIP INCUnited StatesDesign verification does not confirm that design output meets design input requirements.
Jan 8, 20264DMedical Ltd.AustraliaProcedures for design verification have not been adequately established.
Dec 22, 2025Ashland Specialty Ingredients, G.P.United StatesProcedures for design verification have not been adequately established.
Dec 19, 2025Excel Medical Electronics LLCUnited StatesProcedures for design verification have not been adequately established.
Dec 18, 2025Pro2Health, Inc.United StatesDesign verification does not confirm that design output meets design input requirements.
Dec 12, 2025MedLine Industries, LP (NAMIC Division)United StatesProcedures for design verification have not been adequately established.
Nov 7, 2025Kerber USA Inc.United StatesThe design verification results, including identification of the design, method(s), the date and the individual(s) performing the verification, were not documented in the design history file.
Nov 5, 2025Intuitive Surgical, Inc.United StatesProcedures for design verification have not been adequately established.
Oct 28, 2025Criticare Technologies, Inc.United StatesDesign verification does not confirm that design output meets design input requirements.
Oct 20, 2025McLaren FlintUnited StatesProcedures for design verification have not been adequately established.
Sep 19, 2025Tuxedo ImagingUnited StatesProcedures for design verification have not been established.
Aug 27, 2025Exactech, Inc.United StatesDesign verification does not confirm that design output meets design input requirements.
Aug 26, 2025Magellan Diagnostics, Inc.United StatesProcedures for design verification have not been adequately established.
Aug 21, 2025Tri-Anim Health Services, Inc.United StatesDesign verification does not confirm that design output meets design input requirements.
Aug 19, 2025DGI Group LLCUnited StatesDesign verification does not confirm that design output meets design input requirements.
Aug 19, 2025Diasol, IncUnited StatesProcedures for design verification have not been adequately established.
Jun 12, 2025Forward Science Technologies LLCUnited StatesDesign verification does not confirm that design output meets design input requirements.
May 16, 2025Blue Elephant IncUnited StatesThe design verification results, including identification of the design, method(s), the date and the individual(s) performing the verification, were not documented in the design history file.
May 13, 2025Fisher Wallace Laboratories Inc.United StatesProcedures for design verification have not been adequately established.
Apr 23, 2025Miach OrthopaedicsUnited StatesDesign verification does not confirm that design output meets design input requirements.
Apr 7, 2025Boston Scientific CorporationUnited StatesProcedures for design verification have not been adequately established.
Mar 4, 2025Soleva Pharma LlcUnited StatesProcedures for design verification have not been adequately established.
Feb 5, 2025NeuroSync, Inc.United StatesDesign verification does not confirm that design output meets design input requirements.
Jan 24, 2025Microlight Corporation Of AmericaUnited StatesThe design verification results, including identification of the design, method(s), the date and the individual(s) performing the verification, were not documented in the design history file.
Jan 9, 2025Helena Laboratories UK LtdUnited KingdomDesign verification does not confirm that design output meets design input requirements.

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