Home / CFR sections / 21 CFR 820.30(j)

21 CFR 820.30(j) citations

Design history file

FDA investigators cited 21 CFR 820.30(j) 471 times at 430 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 31, 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
20268
202527
202431
202324
202222
20219
202018
201928
201834
201730

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 31, 2025Peter Schiff EnterprisesUnited StatesThe design history file was not established.
Dec 12, 2025Foresight Imaging, LLCUnited StatesThe design history file was not established.
Dec 10, 20253B Medical, Inc.United StatesThe design history file does not demonstrate that the design was developed following the approved design plan.
Nov 21, 20253D Diagnostix Inc.United StatesThe design history file was not established.
Nov 5, 2025R.G. Enterprises (U.S.A.) Inc.United StatesThe design history file was not established.
Oct 30, 2025Longhorn Vaccines And Diagnostics LLCUnited StatesThe design history file was not established.
Oct 22, 2025Merchsource LLCUnited StatesThe design history file was not established.
Oct 8, 2025Safer Medical Products Inc.United StatesThe design history file was not established.
Sep 25, 2025Integrity United IncUnited StatesThe design history file was not established.
Sep 19, 2025Tuxedo ImagingUnited StatesThe design history file was not established.
Aug 28, 2025Fogless International ABSwedenThe design history file was not established, does not demonstrate that the design was developed following the approved design plan and does not demonstrate that the design was developed following the requirements of 21…
Aug 19, 2025Diasol, IncUnited StatesThe design history file was not established.
Aug 7, 2025Hong Qiangxing (Shen Zhen) Electronics LimitedChinaThe design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Jul 16, 2025GWR Medical, Inc.United StatesThe design history file was not established.
Jun 18, 2025Sheffield Pharmaceuticals, LLCUnited StatesThe design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Jun 5, 2025Somnics, Inc.TaiwanThe design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Jun 2, 2025VALENCIA NATURALS, INCUnited StatesThe design history file was not established.
May 29, 2025Optim LLCUnited StatesThe design history file was not established and does not demonstrate that the design was developed following the approved design plan.
May 16, 2025Blue Elephant IncUnited StatesThe design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
May 9, 2025The Feminina Group, Inc.United StatesThe design history file was not established.
May 6, 2025US Hyperbaric Network LLCUnited StatesThe design history file was not established and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Apr 28, 2025Truemed Group LLCUnited StatesThe design history file was not established.
Apr 23, 2025R-Med IncUnited StatesThe design history file was not established.
Apr 17, 2025Advanced Instrumentations, Inc.United StatesThe design history file does not demonstrate that the design was developed following the approved design plan.
Apr 11, 2025Elevate Textiles, Inc.United StatesThe design history file was not established and does not demonstrate that the design was developed following the requirements of 21 CFR 820.

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