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21 CFR 820.72(a) citations

Equipment suitability & capability

FDA investigators cited 21 CFR 820.72(a) 913 times at 783 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Dec 11, 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
202535
202437
202352
202237
202110
202031
201964
201872
201761

Recent citations

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

Inspection endedFacilityCountryObservation
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesProcedures to ensure equipment is routinely calibrated have not been adequately established.
Nov 25, 2025Digirad Diagnostic Imaging, LLCUnited StatesProcedures to ensure equipment is routinely calibrated and maintained have not been adequately established.
Nov 24, 2025Creative Foam Corporation - BremenUnited StatesProcedures to ensure equipment is routinely calibrated have not been adequately established.
Nov 7, 2025Kerber USA Inc.United StatesEquipment calibrations have not been documented.
Nov 6, 2025Akervall Technologies, Inc.United StatesProcedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been established.
Nov 5, 2025Drake Precision Dental LaboratoryUnited StatesEquipment calibrations have not been documented.
Oct 30, 2025Retmap IncUnited StatesEquipment maintenance activities have not been documented.
Oct 22, 2025LightwaveUnited StatesProcedures to ensure equipment is routinely calibrated and inspected have not been established.
Sep 26, 2025Slater Endoscopy, LLCUnited StatesProcedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
Sep 12, 2025Bradshaw Medical, Inc.United StatesProcedures to ensure equipment is routinely maintained have not been adequately established.
Sep 11, 2025Diversified Healthcare Development LLCUnited StatesProcedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been established.
Aug 27, 2025Realized Mfg LLCUnited StatesProcedures to ensure equipment is routinely calibrated and maintained have not been adequately established.
Aug 21, 2025Gb Implantat Technologie GMBHGermanyEquipment calibrations have not been documented.
Aug 7, 2025Ashland Specialty Ingredients, G.P.United StatesProcedures to ensure equipment is routinely calibrated and inspected have not been adequately established.
Aug 7, 2025RAC Medical SolutionsUnited StatesProcedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been established.
Aug 5, 2025Carroll-Baccari IncUnited StatesProcedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
Jul 30, 2025Serim Research CorporationUnited StatesProcedures to ensure equipment is routinely calibrated and maintained have not been adequately established.
Jul 18, 2025Microvapor Devices LLCUnited StatesEquipment calibrations have not been documented.
Jul 3, 2025Caltag Medsystems LtdUnited KingdomProcedures to ensure equipment is routinely calibrated and maintained have not been adequately established.
Jul 2, 2025Envoy Medical CorporationUnited StatesProcedures to ensure equipment is routinely calibrated have not been adequately established.
Jul 1, 2025Millar, Inc.United StatesEquipment checks and maintenance activities have not been documented.
Jun 18, 2025ActivePure Manufacturing LLC, A Wholly Owned Subsidiary Of ActivePure Technologies LLCUnited StatesProcedures to ensure equipment is routinely calibrated have not been adequately established.
Jun 18, 2025Physitemp Instruments, LLCUnited StatesCertain test equipment is not capable of producing valid results.
Jun 10, 2025EyeKon Medical, Inc.United StatesProcedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
Jun 5, 2025McGinley Orthopaedic Innovations LLCUnited StatesProcedures to ensure equipment is routinely calibrated and checked have not been adequately 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.