21 CFR 803.50(a)(1) citations

Report of Death or Serious Injury

FDA investigators cited 21 CFR 803.50(a)(1) 402 times at 343 facilities in the inspection citations FDA publishes, most recently in an inspection that ended May 19, 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 year	Citations
2026	5
2025	16
2024	8
2023	16
2022	9
2021	9
2020	6
2019	18
2018	30
2017	25

Recent citations

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

Inspection ended	Facility	Country	Observation
May 19, 2026	Biofilm, Inc.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Mar 19, 2026	Mobia Medical Inc	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Feb 18, 2026	BioTissue Holdings Inc	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Dec 9, 2025	Mid Central Medical, LLC.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Nov 5, 2025	Intuitive Surgical, Inc.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Aug 13, 2025	Nevro Corporation	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Aug 5, 2025	Abiomed, Inc.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Aug 1, 2025	ASP Global, LLC.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Jul 25, 2025	Keystone Industries	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Jun 12, 2025	Sophysa	France	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
May 13, 2025	Fisher Wallace Laboratories Inc.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Mar 14, 2025	Hospi Corporation	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Mar 14, 2025	Topcon Medical Systems, Inc.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Mar 7, 2025	SOADCO, S.L.	Andorra	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Feb 6, 2025	Sonavex, Inc.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Nov 27, 2024	Augustine Temperature Management, LLC	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Nov 26, 2024	Atrium Medical Corporation	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Nov 26, 2024	Noah Medical Corporation	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Oct 30, 2024	Allied Medical LLC	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Oct 10, 2024	NOA Medical Industries Inc	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Oct 7, 2024	Brius Technologies Inc.	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Sep 26, 2024	OSTEOPORE INTERNATIONAL PTE LTD	Singapore	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Aug 21, 2024	Axis Spine Technologies Ltd.	United Kingdom	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Jul 11, 2024	Maquet Cardiovascular, LLC	United States	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
May 2, 2024	Creo Medical LTD	United Kingdom	An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

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