21 CFR 820.90(a) citations
FDA investigators cited 21 CFR 820.90(a) 1,786 times at 1,499 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 | 22 |
| 2025 | 103 |
| 2024 | 89 |
| 2023 | 100 |
| 2022 | 67 |
| 2021 | 26 |
| 2020 | 65 |
| 2019 | 122 |
| 2018 | 132 |
| 2017 | 141 |
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 | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Jan 16, 2026 | Marson Medical, Inc. | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Jan 9, 2026 | Encore Laboratory | United States | Products that do not conform to specifications are not adequately controlled. |
| Jan 8, 2026 | Vortex Surgical Inc. | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Dec 31, 2025 | Peter Schiff Enterprises | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Dec 11, 2025 | Hatch Product Development LLC | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Dec 5, 2025 | Safesource Direct LLC | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Dec 5, 2025 | Superior Felt & Filtration, L.L.C. | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Nov 24, 2025 | Creative Foam Corporation - Bremen | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Nov 21, 2025 | OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | Japan | Products that do not conform to specifications are not adequately controlled. |
| Nov 19, 2025 | PRENOSIS INC | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Nov 17, 2025 | Pathright Medical Inc | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Nov 14, 2025 | Elastic Therapy, LLC | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Nov 12, 2025 | Gyrus ACMI, Inc. | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Nov 6, 2025 | Akervall Technologies, Inc. | United States | Procedures have not been established to control product that does not conform to specified requirements. |
| Nov 5, 2025 | R.G. Enterprises (U.S.A.) Inc. | United States | Procedures have not been established to control product that does not conform to specified requirements. |
| Oct 30, 2025 | Retmap Inc | United States | Procedures have not been established to control product that does not conform to specified requirements. |
| Oct 30, 2025 | Splintek, Inc | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Oct 24, 2025 | IRAY IMAGING LLC | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Oct 22, 2025 | Lightwave | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Oct 14, 2025 | AHA TECHNOLOGIES, INC. | United States | Procedures have not been established to control product that does not conform to specified requirements. |
| Oct 10, 2025 | Stephen Gould Corporation | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Sep 26, 2025 | Moebius Precision Corporation | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Sep 25, 2025 | ARCH Medical Solutions - Elmhurst | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
| Sep 25, 2025 | Armbrust Inc. | United States | Procedures have not been adequately established to control product that does not conform to specified requirements. |
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