21 CFR 803.50(a)(2) citations
FDA investigators cited 21 CFR 803.50(a)(2) 549 times at 456 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 24, 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 | 15 |
| 2025 | 23 |
| 2024 | 29 |
| 2023 | 32 |
| 2022 | 19 |
| 2021 | 3 |
| 2020 | 13 |
| 2019 | 21 |
| 2018 | 26 |
| 2017 | 30 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jul 24, 2026 | King Brand Healthcare Products | 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 has malfunctioned and would be likely to cause or contribute to a… |
| Jul 23, 2026 | BIOPSYBELL S.R.L. | Italy | An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a… |
| May 26, 2026 | Biowave 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 has malfunctioned and would be likely to cause or contribute to a… |
| Mar 12, 2026 | Fehling Instruments GmbH & Co. KG | Germany | An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a… |
| Mar 12, 2026 | Fudakang Industrial Co Ltd | China | An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a… |
| Jan 12, 2026 | ZIIP 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 has malfunctioned and would be likely to cause or contribute to a… |
| Dec 18, 2025 | ZIOSOFT, INC. | Japan | An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a… |
| Nov 21, 2025 | Olympus Winter & IBE Gmbh | Germany | An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a… |
| Nov 17, 2025 | Pathright 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 has malfunctioned and would be likely to cause or contribute to a… |
| Nov 6, 2025 | GETSET SURGICAL SA | Switzerland | An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a… |
| Oct 23, 2025 | Abbott Diabetes Care, 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 has malfunctioned and would be likely to cause or contribute to a… |
| Oct 20, 2025 | McLaren Flint | 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 has malfunctioned and would be likely to cause or contribute to a… |
| Oct 16, 2025 | Globus 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 has malfunctioned and would be likely to cause or contribute to a… |
| Oct 16, 2025 | Silq Technologies 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 has malfunctioned and would be likely to cause or contribute to a… |
| Oct 6, 2025 | Biogenex 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 has malfunctioned and would be likely to cause or contribute to a… |
| Sep 18, 2025 | Zyno 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 has malfunctioned and would be likely to cause or contribute to a… |
| Aug 29, 2025 | CPM Medical Consultants, 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 has malfunctioned and would be likely to cause or contribute to a… |
| Aug 26, 2025 | Magellan Diagnostics, 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 has malfunctioned and would be likely to cause or contribute to a… |
| Aug 19, 2025 | Diasol, 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 has malfunctioned and would be likely to cause or contribute to a… |
| Aug 1, 2025 | Roche Diagnostics GmbH | Germany | An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a… |
| Jul 23, 2025 | Hiossen 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 has malfunctioned and would be likely to cause or contribute to a… |
| Jul 16, 2025 | Katalyst Surgical, 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 has malfunctioned and would be likely to cause or contribute to a… |
| Jul 4, 2025 | Implanet | 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 has malfunctioned and would be likely to cause or contribute to a… |
| Jun 13, 2025 | Pinnacle Biologics 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 has malfunctioned and would be likely to cause or contribute to a… |
| Jun 12, 2025 | RENISHAW MAYFIELD | 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 has malfunctioned and would be likely to cause or contribute to a… |
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