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21 CFR 803.17 citations

Lack of Written MDR Procedures

FDA investigators cited 21 CFR 803.17 1,701 times at 1,544 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 1, 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
20271
202650
202560
202450
202354
202261
202131
202064
2019129
2018124

Recent citations

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

Inspection endedFacilityCountryObservation
Oct 1, 2026Jazz ImagingUnited StatesWritten MDR procedures have not been developed.
Sep 11, 2026Revolutionary ScienceUnited StatesWritten MDR procedures have not been implemented.
Aug 21, 2026Neurotron, Inc.United StatesWritten MDR procedures have not been developed.
Aug 14, 2026Vitalcor, Inc.United StatesWritten MDR procedures have not been developed, maintained and implemented.
Aug 13, 2026ECLOSIONUnited StatesWritten MDR procedures have not been developed, maintained and implemented.
Aug 11, 2026Superior Labs IncUnited StatesWritten MDR procedures have not been developed and implemented.
Aug 6, 2026Metropolis International LLCUnited StatesWritten MDR procedures have not been developed and maintained.
Jul 24, 2026Louis M. Gerson Co., Inc.United StatesWritten MDR procedures have not been developed and maintained.
Jul 23, 2026Creodent Hudson ValleyUnited StatesWritten MDR procedures have not been maintained.
Jul 10, 2026CARE LIVING DIAGNOSTICS INCUnited StatesWritten MDR procedures have not been developed.
Jul 9, 2026Hospitec UsaUnited StatesWritten MDR procedures have not been developed.
Jun 30, 2026AIRGLE CORPORATIONUnited StatesWritten MDR procedures have not been maintained.
Jun 25, 2026Aus Systems Pty LtdAustraliaWritten MDR procedures have not been developed, maintained and implemented.
Jun 25, 2026Tektone Sound & Signal Mfg.Inc.United StatesWritten MDR procedures have not been implemented.
Jun 24, 2026Sleep Joy International LLCUnited StatesWritten MDR procedures have not been developed.
Jun 12, 2026Comfortland Medical, Inc.United StatesWritten MDR procedures have not been developed, maintained and implemented.
May 22, 2026Contego Medical, IncUnited StatesWritten MDR procedures have not been implemented.
May 13, 2026Theo Manufacturing BVNetherlandsWritten MDR procedures have not been developed, maintained and implemented.
May 7, 2026DAWA MEDICAL LLCUnited StatesWritten MDR procedures have not been developed, maintained and implemented.
Apr 29, 2026PureWave Life LLCUnited StatesWritten MDR procedures have not been developed.
Apr 24, 2026Pourang Bral, DDS, LLCUnited StatesWritten MDR procedures have not been implemented.
Apr 23, 2026Medify Air LLCUnited StatesWritten MDR procedures have not been developed and maintained.
Apr 21, 2026Onanon IncUnited StatesWritten MDR procedures have not been developed.
Apr 16, 2026Emerald Supply IncUnited StatesWritten MDR procedures have not been developed, maintained and implemented.
Apr 10, 2026All Quality & Services, Inc.United StatesWritten MDR procedures have not been developed.

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