21 CFR 820.40 citations
FDA investigators cited 21 CFR 820.40 1,026 times at 923 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 | 11 |
| 2025 | 38 |
| 2024 | 34 |
| 2023 | 38 |
| 2022 | 46 |
| 2021 | 18 |
| 2020 | 43 |
| 2019 | 74 |
| 2018 | 45 |
| 2017 | 81 |
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 | DASISIMULATIONS, LLC | United States | Document control procedures have not been adequately established. |
| Jan 16, 2026 | Marson Medical, Inc. | United States | Document control procedures have not been adequately established. |
| Jan 15, 2026 | EPS Bio Technology Corp. | Taiwan | Document control procedures have not been established. |
| Dec 11, 2025 | Specialty Health Products CO, LLC | United States | Document control procedures have not been adequately established. |
| Nov 19, 2025 | Tobra Medical Inc | United States | Document control procedures have not been adequately established. |
| Nov 12, 2025 | Banyan USA LLC | United States | Document control procedures have not been established. |
| Nov 10, 2025 | Procurement Network, Inc. | United States | Document control procedures have not been adequately established. |
| Nov 5, 2025 | R.G. Enterprises (U.S.A.) Inc. | United States | Document control procedures have not been established. |
| Oct 22, 2025 | Lightwave | United States | Document control procedures have not been adequately established. |
| Oct 22, 2025 | Merchsource LLC | United States | Document control procedures have not been established. |
| Oct 14, 2025 | AHA TECHNOLOGIES, INC. | United States | Document control procedures have not been adequately established. |
| Sep 26, 2025 | Moebius Precision Corporation | United States | Document control procedures have not been adequately established. |
| Sep 25, 2025 | Integrity United Inc | United States | Document control procedures have not been established. |
| Sep 24, 2025 | Neurolumen LLC | United States | Document control procedures have not been adequately established. |
| Sep 19, 2025 | Tuxedo Imaging | United States | Document control procedures have not been adequately. |
| Sep 18, 2025 | VirtuSense Technologies, Inc. | United States | Document control procedures have not been established. |
| Sep 5, 2025 | MRIAUDIO, INC. | United States | Document control procedures have not been established and maintained. |
| Sep 4, 2025 | Clearadvance, LLC | United States | Document control procedures have not been adequately established. |
| Sep 4, 2025 | Polyganics Holding BV | Netherlands | Document control procedures have not been adequately established. |
| Aug 21, 2025 | Georgia High Tech Dental Lab Inc | United States | Document control procedures have not been adequately established. |
| Aug 19, 2025 | Diasol, Inc | United States | Document control procedures have not been adequately established. |
| Aug 5, 2025 | Carroll-Baccari Inc | United States | Document control procedures have not been adequately established. |
| Jul 8, 2025 | FC Company Limited | Hong Kong SAR | Document control procedures have not been adequately established and maintained. |
| Jun 30, 2025 | Integrity Dental Services LLC | United States | Document control procedures have not been established. |
| Jun 27, 2025 | Medspira, LLC | United States | Document control procedures have not been adequately established. |
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