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21 CFR 820.30(e) citations

Design reviews performed following schedule

FDA investigators cited 21 CFR 820.30(e) 345 times at 330 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 5, 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
20262
202512
20247
202314
20227
20211
202012
201922
201819
201722

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 5, 2025Safesource Direct LLCUnited StatesProcedures for design review have not been adequately established.
Nov 7, 2025Kerber USA Inc.United StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Sep 19, 2025Tuxedo ImagingUnited StatesProcedures for design review have not been established.
Aug 22, 2025Coronado Aesthetics LLCUnited StatesProcedures for design review have not been adequately established.
Aug 19, 2025DGI Group LLCUnited StatesProcedures for design review have not been adequately established.
Jul 30, 2025Austco Marketing & Service LTD.United StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Jun 9, 2025CPAC Equipment, Inc.United StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
May 16, 2025Blue Elephant IncUnited StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Apr 24, 2025Pedia Parents Inc.United StatesProcedures for design review have not been adequately established.
Mar 7, 2025SOADCO, S.L.AndorraProcedures for design review have not been adequately established.
Feb 3, 2025Lingraphicare America, Inc.United StatesProcedures for design review have not been established.
Jan 24, 2025Microlight Corporation Of AmericaUnited StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Dec 6, 2024Advanced Tactile Imaging, Inc.United StatesProcedures for design review have not been adequately established.
Nov 6, 2024AXILUM ROBOTICS SASFranceThe design review results, including the individual(s) performing the review, were not documented in the design history file.
Mar 6, 2024Radialogica LLCUnited StatesProcedures for design review have not been adequately established.
Feb 23, 2024ORAL IQ LLCUnited StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Feb 12, 2024Solevy Co. LLCUnited StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Jan 18, 2024Macromedics BVNetherlandsProcedures for design review have not been adequately established.
Dec 7, 2023TR Equipment ABSwedenProcedures for design review have not been established.
Nov 2, 2023DK MEDICAL SYSTEMS CO., LTD.Korea (the Republic of)Procedures for design review have not been adequately established.
Oct 12, 2023WECO MANUFACTURING GROUP-HENRIETTA/ ESIUnited StatesThe design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.
Sep 7, 2023SWORD HEALTH S.A.PortugalProcedures for design review have not been adequately established.
Jul 27, 2023Innolatex Sdn. Bhd.MalaysiaProcedures for design review have not been adequately established.
Jun 30, 2023Advance Medical Designs, Inc.United StatesProcedures for design review have not been adequately established.
Apr 13, 2023GEO Medical Co., Ltd.Korea (the Republic of)Procedures for design review have not been adequately established.

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