21 CFR 820.184 citations
FDA investigators cited 21 CFR 820.184 1,793 times at 1,517 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 year | Citations |
|---|---|
| 2026 | 19 |
| 2025 | 84 |
| 2024 | 78 |
| 2023 | 100 |
| 2022 | 72 |
| 2021 | 28 |
| 2020 | 41 |
| 2019 | 116 |
| 2018 | 115 |
| 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 16, 2026 | Marson Medical, Inc. | United States | Procedures for device history records have not been established. |
| Jan 9, 2026 | Encore Laboratory | United States | The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820. |
| Dec 31, 2025 | Peter Schiff Enterprises | United States | A device history record has not been maintained. |
| Dec 22, 2025 | Ashland Specialty Ingredients, G.P. | United States | A device history record has not been adequately maintained. |
| Dec 17, 2025 | Ventec Life Systems, Inc. | United States | The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820. |
| Dec 11, 2025 | Specialty Health Products CO, LLC | United States | The device history record does not demonstrate that the device was manufactured in accordance with the device master record. |
| Nov 21, 2025 | 3D Diagnostix Inc. | United States | Procedures for device history records have not been adequately established. |
| Nov 19, 2025 | Blephex, LLC | United States | Procedures for device history records have not been established. |
| Nov 12, 2025 | Gyrus ACMI, Inc. | United States | Procedures for device history records have not been adequately established. |
| Nov 7, 2025 | Kerber USA Inc. | United States | Procedures for device history records have not been adequately established. |
| Nov 5, 2025 | Drake Precision Dental Laboratory | United States | The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820. |
| Nov 5, 2025 | Medidenta | United States | Procedures for device history records have not been adequately established. |
| Oct 24, 2025 | PADCO HOLDING COMPANY, LLC | United States | Procedures for device history records have not been established. |
| Oct 23, 2025 | Sheffield Precision Medical Limited | United Kingdom | The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820. |
| Oct 22, 2025 | Lightwave | United States | Procedures for device history records have not been established. |
| Oct 22, 2025 | Merchsource LLC | United States | Procedures for device history records have not been adequately established. |
| Oct 22, 2025 | Sodium Systems LLC | United States | The device history record does not demonstrate that the device was manufactured in accordance with the device master record. |
| Oct 16, 2025 | VENTURE SOLUTIONS | United States | Procedures for device history records have not been established. |
| Oct 8, 2025 | Safer Medical Products Inc. | United States | A device history record has not been maintained. |
| Sep 26, 2025 | G3 Medical | United States | The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820. |
| Sep 25, 2025 | Integrity United Inc | United States | Procedures for device history records have not been established. |
| Sep 25, 2025 | Mesco, Inc. | Philippines | A device history record has not been maintained. |
| Sep 25, 2025 | Mesco, Inc. | Philippines | The device history record does not demonstrate that the device was manufactured in accordance with the device master record. |
| Sep 19, 2025 | Tuxedo Imaging | United States | Procedures for device history records have not been established. |
| Sep 18, 2025 | BCM Co., Ltd. | Korea (the Republic of) | A device history record has not been adequately maintained. |
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