21 CFR 820.50 citations
FDA investigators cited 21 CFR 820.50 1,632 times at 1,345 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 15, 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 | 23 |
| 2025 | 104 |
| 2024 | 72 |
| 2023 | 82 |
| 2022 | 76 |
| 2021 | 29 |
| 2020 | 59 |
| 2019 | 135 |
| 2018 | 129 |
| 2017 | 121 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jan 15, 2026 | MIDWAY MEDICAL | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established. |
| Dec 31, 2025 | Peter Schiff Enterprises | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Dec 18, 2025 | ZIOSOFT, INC. | Japan | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Dec 11, 2025 | Specialty Health Products CO, LLC | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Dec 9, 2025 | Moldworks Worldwide LLC | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Dec 3, 2025 | ASEPTIKITS, LLC | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 25, 2025 | Digirad Diagnostic Imaging, LLC | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 21, 2025 | 3D Diagnostix Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 21, 2025 | Olympus Winter & IBE Gmbh | Germany | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 14, 2025 | Shirakawa Olympus Co., Ltd. | Japan | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 12, 2025 | Gyrus ACMI, Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 10, 2025 | Dualams, Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 6, 2025 | Akervall Technologies, Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 5, 2025 | Intuitive Surgical, Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Nov 5, 2025 | R.G. Enterprises (U.S.A.) Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established. |
| Oct 29, 2025 | Empowered Products, Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Oct 28, 2025 | Criticare Technologies, Inc. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Oct 27, 2025 | RG Medical USA | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Oct 24, 2025 | PADCO HOLDING COMPANY, LLC | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Oct 22, 2025 | Lightwave | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Oct 22, 2025 | Sodium Systems LLC | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Oct 16, 2025 | Kent Elastomer Products Inc | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
| Oct 14, 2025 | AHA TECHNOLOGIES, INC. | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established. |
| Sep 25, 2025 | Integrity United Inc | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established. |
| Sep 24, 2025 | Neurolumen LLC | United States | Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. |
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