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21 CFR 820.70(a) citations

Production processes

FDA investigators cited 21 CFR 820.70(a) 928 times at 823 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
20267
202541
202434
202331
202226
20216
202031
201948
201856
201773

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 StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.
Jan 13, 2026Curative Sound LLCUnited StatesProduction processes were not developed to ensure that a device conforms to its specifications.
Dec 11, 2025Specialty Health Products CO, LLCUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Oct 28, 2025Criticare Technologies, Inc.United StatesProduction processes were not developed to ensure that a device conforms to its specifications.
Oct 24, 2025GRAMERCY EXTREMITY ORTHOPEDICSUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Oct 22, 2025LightwaveUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Oct 10, 2025Stephen Gould CorporationUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Sep 26, 2025Viant Medical, Inc.United StatesProduction processes were not monitored to ensure that a device conforms to its specifications.
Sep 18, 2025ANDERSEN CALEDONIA LTDUnited KingdomProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Sep 18, 2025ICU Medical Czech Republic A. S.Czech RepublicProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Sep 5, 2025Keter Canada, Inc.CanadaProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.
Aug 25, 2025Varex Imaging CorporationUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Aug 19, 2025Diasol, IncUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Aug 13, 2025Nevro CorporationUnited StatesProduction processes were not controlled to ensure that a device conforms to its specifications.
Aug 5, 2025Carroll-Baccari IncUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Aug 1, 2025Autocam Medical Devices, LLC.United StatesProduction processes were not monitored to ensure that a device conforms to its specifications.
Aug 1, 2025etectRX LLC.United StatesProduction processes were not developed, conducted, controlled and monitored to ensure that a device conforms to its specifications.
Jul 31, 2025Euromi S.A.BelgiumProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Jul 31, 2025Myriad Fiber Imaging Technologies, Inc.United StatesProduction processes were not conducted, controlled and monitored to ensure that a device conforms to its specifications.
Jul 25, 2025Exactech Sarasota, Inc.United StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Jul 25, 2025Keystone IndustriesUnited StatesProduction processes were not conducted and controlled to ensure that a device conforms to its specifications.
Jul 24, 2025ATZ ManufacturingUnited StatesProduction processes were not developed to ensure that a device conforms to its specifications.
Jul 23, 2025Woven Orthopedic Technologies, LLCUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.
Jun 18, 2025L Z FORM KFTHungaryProcess control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Jun 4, 2025Cook IncorporatedUnited StatesProcess control procedures that describe any process controls necessary to ensure conformance to specifications 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.