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21 CFR 820.198(c) citations

Investigation of device failures

FDA investigators cited 21 CFR 820.198(c) 733 times at 630 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
20266
202515
202412
202329
202223
202117
202013
201932
201848
201745

Recent citations

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

Inspection endedFacilityCountryObservation
Jan 13, 2026Nuclein LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Nov 14, 2025Shirakawa Olympus Co., Ltd.JapanComplaints involving the possible failure of a device to meet any of its specifications were not where necessary.
Nov 5, 2025PNEO, LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Nov 4, 2025Hologic, IncUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Oct 30, 2025Vesalio, Inc.United StatesComplaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Oct 20, 2025McLaren FlintUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Aug 20, 2025Facemaster Of Beverly Hills, Inc.United StatesComplaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary.
Aug 20, 2025Pharmacaribe, LLCUnited StatesComplaints involving the possible failure of labeling to meet any of its specifications were not evaluated and investigated where necessary.
Jul 24, 2025Medtech SASFranceComplaints involving the possible failure of a device, labeling and packaging to meet any of its specifications were not investigated where necessary.
Jul 18, 2025Leesar IncUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Jul 18, 2025Microvapor Devices LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Jun 12, 2025Infus Medical Co., Ltd.ThailandComplaints involving the possible failure of a device and packaging to meet any of its specifications were not investigated where necessary.
Jun 6, 2025Transdermal Cap Inc.United StatesComplaints involving the possible failure of a device to meet any of its specifications were not evaluated and investigated where necessary.
Jun 5, 2025Portal 724 LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
May 2, 2025Focus Medical, LLCUnited StatesComplaints involving the possible failure of to meet any of its specifications were not investigated where necessary.
Apr 7, 2025Neogen CorporationUnited StatesComplaints involving the possible failure of labeling to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Feb 4, 2025Evoqua Water Technologies LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Jan 24, 2025Microlight Corporation Of AmericaUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Nov 26, 2024Atrium Medical CorporationUnited StatesComplaints involving the possible failure of a device and labeling to meet any of its specifications were not reviewed and investigated where necessary.
Nov 22, 2024Axiobionics, LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Oct 7, 2024Brius Technologies Inc.United StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
Jun 21, 2024Aerscher Diagnostics, LLCUnited StatesComplaints involving the possible failure of packaging to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
May 31, 2024Robbins Instruments, LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.
May 10, 2024Inspire Medical Systems Inc.United StatesComplaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary.
Apr 12, 2024Apneicare LLCUnited StatesComplaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated and investigated where necessary.

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