Home / CFR sections / 21 CFR 820.198(e)

21 CFR 820.198(e) citations

Records of complaint investigation - UDI

FDA investigators cited 21 CFR 820.198(e) 342 times at 321 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 14, 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
20262
202516
202412
202321
20225
20214
20208
201922
201821
201730

Recent citations

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

Inspection endedFacilityCountryObservation
Jul 14, 2026Bionix, LlcUnited StatesRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Oct 22, 2025Sodium Systems LLCUnited StatesRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Sep 16, 2025Metric Medical Devices IncUnited StatesRecords of complaint investigations do not include required information.
Sep 4, 2025In2Bones, SASFranceRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Aug 15, 20253D Medical Manufacturing, Inc.United StatesRecords of complaint investigations do not include required information.
Jul 31, 2025Michigan Instruments, Inc.United StatesRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Jun 13, 2025Cognivue Inc.United StatesRecords of complaint investigations do not include required information.
May 22, 2025Altimate Medical, Inc.United StatesRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
May 15, 2025Directmed, IncUnited StatesRecords of complaint investigations do not include required information.
Apr 4, 2025Cancer Diagnostics Inc.United StatesRecords of complaint investigations are not maintained by the formally designated unit.
Mar 26, 2025Innovize LLCUnited StatesRecords of complaint investigations do not include required information.
Mar 7, 2025Harmonic Energetic Technologies Inc.United StatesRecords of complaint investigations do not include required information.
Mar 7, 2025Ruhof CorporationUnited StatesRecords of complaint investigations do not include required information.
Feb 7, 2025Aprios Custom MfgUnited StatesRecords of complaint investigations are not maintained by the formally designated unit.
Jan 31, 2025Brain Tunnelgenix TechnologiesUnited StatesRecords of complaint investigations are not maintained by the formally designated unit.
Jan 10, 2025Angiodynamics, Inc.United StatesRecords of complaint investigations do not include required information.
Nov 26, 2024BC3 TECHNOLOGIESUnited StatesRecords of complaint investigations are not maintained by the formally designated unit.
Nov 7, 2024DRG Instruments GmbHGermanyRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Aug 22, 2024Percussionaire CorporationUnited StatesRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Aug 21, 2024Knox Medical Diagnostics, Inc.United StatesRecords of complaint investigations do not include required information.
Apr 11, 2024Vygon Portugal - Produtos Medicos E Farmaceuticos, LdaPortugalRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Apr 5, 2024Efer EndoscopyFranceRecords of complaint investigations do not include required information.
Apr 4, 2024Sage Product Development, Inc.United StatesRecords of complaint investigations do not include required information.
Apr 3, 2024General Hospital Supply Corp.United StatesRecords of complaint investigations do not include required information, including any unique device identifier (UDI) or universal product code (UPC).
Mar 15, 2024Orion Vision GroupUnited StatesRecords of complaint investigations do not include required information.

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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.