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21 CFR 820.30(a) citations

Design control - no procedures

FDA investigators cited 21 CFR 820.30(a) 679 times at 608 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 13, 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
20268
202536
202423
202328
202228
202113
202022
201952
201851
201739

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 13, 2026Curative Sound LLCUnited StatesProcedures for design control have not been established.
Dec 12, 2025BAND CONNECTUnited StatesProcedures for design control have not been established.
Dec 3, 2025ASEPTIKITS, LLCUnited StatesProcedures for design control have not been established.
Nov 21, 2025Olympus Medical Systems CorporationJapanProcedures for design control have not been established.
Nov 19, 2025Blephex, LLCUnited StatesProcedures for design control have not been established.
Nov 5, 2025R.G. Enterprises (U.S.A.) Inc.United StatesProcedures for design control have not been established.
Oct 22, 2025LightwaveUnited StatesProcedures for design control have not been established.
Oct 14, 2025AHA TECHNOLOGIES, INC.United StatesProcedures for design control have not been established.
Sep 5, 2025MRIAUDIO, INC.United StatesProcedures for design control have not been established.
Aug 8, 2025Tactical Medical Solutions, Thermal Management GroupUnited StatesProcedures for design control have not been established.
Jul 2, 2025Thompson Ocular Prosthetics, IncUnited StatesProcedures for design control have not been established.
Jun 12, 2025JAS Diagnostics, Inc./Drew Scientific, Inc.United StatesProcedures for design control have not been established.
May 30, 2025CMI Health, Inc.United StatesProcedures for design control have not been established.
May 20, 2025Baylab USA, LLCUnited StatesProcedures for design control have not been established.
May 9, 2025Smaart Medical Systems, IncUnited StatesProcedures for design control have not been established.
May 9, 2025The Feminina Group, Inc.United StatesProcedures for design control have not been established.
May 8, 2025Aunt Flow CorpUnited StatesProcedures for design control have not been established.
Apr 22, 2025Pulmodyne Inc.United StatesProcedures for design control have not been established.
Apr 21, 2025Technological Medical Advancements LLCUnited StatesProcedures for design control have not been established.
Apr 16, 2025The Richline Group IncUnited StatesProcedures for design control have not been established.
Apr 11, 2025Hansen Ophthalmic Development Laboratory Inc.United StatesProcedures for design control have not been established.
Apr 10, 2025HERSILL, S.L.SpainProcedures for design control have not been established.
Apr 4, 2025Cancer Diagnostics Inc.United StatesProcedures for design control have not been established.
Mar 26, 2025Seniorlife Technologies IncUnited StatesProcedures for design control have not been established.
Mar 18, 2025Stat Medical Devices, Inc.United StatesProcedures for design control have not been established.

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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.