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21 CFR 820.198(a) citations

Lack of or inadequate complaint procedures

FDA investigators cited 21 CFR 820.198(a) 3,905 times at 3,147 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 16, 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
202660
2025218
2024197
2023190
2022147
202154
2020150
2019255
2018241
2017285

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 16, 2026Marson Medical, Inc.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 15, 2026Apex Medical Technologies, Inc.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 15, 2026Expanse Medical Inc.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 15, 2026MIDWAY MEDICALUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
Jan 13, 2026Conformis Inc.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 12, 2026Innova Vascular IncUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 12, 2026ZIIP INCUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 9, 2026Encore LaboratoryUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 8, 20264DMedical Ltd.AustraliaProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Jan 8, 2026Esco Medical Technologies Ltd.LithuaniaProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 31, 2025Peter Schiff EnterprisesUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 19, 2025INSPIRE MEDICAL SYSTEMS INCUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 18, 2025ZIOSOFT, INC.JapanProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 17, 2025Ventec Life Systems, Inc.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 12, 2025BAND CONNECTUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
Dec 12, 2025Black Diamond Video Inc.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 12, 2025Foresight Imaging, LLCUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 11, 2025AVATION MEDICALUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
Dec 11, 2025Hatch Product Development LLCUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 11, 2025Thoracent, LLCUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
Dec 10, 20253B Medical, Inc.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 9, 2025Mid Central Medical, LLC.United StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 5, 2025Bossong Hosiery Mills IncUnited StatesProcedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
Dec 5, 2025Jedmed Instrument CompanyUnited StatesComplaint files are not adequately maintained.

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