21 CFR 820.80(d) citations
FDA investigators cited 21 CFR 820.80(d) 670 times at 615 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 12, 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 | 6 |
| 2025 | 31 |
| 2024 | 21 |
| 2023 | 21 |
| 2022 | 12 |
| 2021 | 6 |
| 2020 | 21 |
| 2019 | 45 |
| 2018 | 38 |
| 2017 | 59 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jan 12, 2026 | Innova Vascular Inc | United States | Procedures for finished device acceptance have not been adequately established. |
| Jan 7, 2026 | Osseofuse International Inc. | United States | Procedures for finished device acceptance have not been adequately established. |
| Dec 31, 2025 | Peter Schiff Enterprises | United States | Procedures for finished device acceptance have not been adequately established. |
| Dec 18, 2025 | DiAgam Societe Anonyme (S.A.) | Belgium | Procedures for finished device acceptance have not been adequately established. |
| Dec 11, 2025 | Hatch Product Development LLC | United States | Procedures for finished device acceptance have not been adequately established. |
| Dec 3, 2025 | ASEPTIKITS, LLC | United States | Procedures for finished device acceptance have not been established. |
| Sep 26, 2025 | Republic Spine, LLC | United States | Procedures for finished device acceptance have not been adequately established. |
| Sep 25, 2025 | Rudolf Storz GmbH | Germany | Procedures for finished device acceptance have not been adequately established. |
| Aug 20, 2025 | UIH Technologies LLC | United States | Procedures for finished device acceptance have not been adequately established. |
| Aug 19, 2025 | Diasol, Inc | United States | Procedures for finished device acceptance have not been adequately established. |
| Aug 15, 2025 | Euclid Vision Corporation | United States | Procedures for finished device acceptance have not been adequately established. |
| Aug 15, 2025 | Sota Precison Optics Inc. | United States | Procedures for finished device acceptance have not been adequately established. |
| Aug 7, 2025 | Magic Science Supply LLC | United States | Procedures for finished device acceptance have not been adequately established. |
| Aug 1, 2025 | STERIS Laboratories, Inc. | United States | Procedures for finished device acceptance have not been adequately established. |
| Jun 18, 2025 | Physitemp Instruments, LLC | United States | Procedures for finished device acceptance have not been adequately established. |
| May 28, 2025 | BRAIN SCIENCE TOOLS BV | Netherlands | Procedures for finished device acceptance have not been adequately established. |
| Apr 23, 2025 | Silex Medical, LLC | United States | Procedures for finished device acceptance have not been established. |
| Apr 22, 2025 | BioAccess, Inc. | United States | Procedures for finished device acceptance have not been adequately established. |
| Mar 26, 2025 | Auxilium Medical Inc. | United States | Procedures for finished device acceptance have not been adequately established. |
| Mar 14, 2025 | Vayuclear Inc | United States | Procedures for finished device acceptance have not been established. |
| Mar 4, 2025 | Reliance Dental Manufacturing LLC | United States | Procedures for finished device acceptance have not been established. |
| Feb 21, 2025 | Rohrer Aesthetics Inc. | United States | Procedures for finished device acceptance have not been adequately established. |
| Feb 18, 2025 | MICROspecialties, LLC | United States | Procedures for finished device acceptance have not been adequately established. |
| Feb 6, 2025 | GEMSS HEALTHCARE CO., LTD. | Korea (the Republic of) | Procedures for finished device acceptance have not been adequately established. |
| Dec 19, 2024 | ALPHANOX CO., LTD. | Korea (the Republic of) | Procedures for finished device acceptance have not been adequately established. |
Search more
Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.