21 CFR 820.75(a) citations
FDA investigators cited 21 CFR 820.75(a) 1,884 times at 1,475 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 | 23 |
| 2025 | 94 |
| 2024 | 79 |
| 2023 | 80 |
| 2022 | 80 |
| 2021 | 24 |
| 2020 | 52 |
| 2019 | 115 |
| 2018 | 127 |
| 2017 | 132 |
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 | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Dec 22, 2025 | Ashland Specialty Ingredients, G.P. | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Dec 18, 2025 | DiAgam Societe Anonyme (S.A.) | Belgium | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Dec 18, 2025 | ZIOSOFT, INC. | Japan | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Dec 12, 2025 | MedLine Industries, LP (NAMIC Division) | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Dec 11, 2025 | KCI POLYMEDICS BV | Belgium | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Nov 24, 2025 | Creative Foam Corporation - Bremen | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Nov 21, 2025 | 3D Diagnostix Inc. | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Nov 21, 2025 | OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | Japan | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Nov 20, 2025 | Precision Edge Surgical Products Co. LLC. | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Nov 14, 2025 | Shirakawa Olympus Co., Ltd. | Japan | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Nov 12, 2025 | Banyan USA LLC | United States | Process validation activities have not been documented. |
| Nov 12, 2025 | Gyrus ACMI, Inc. | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Nov 7, 2025 | AOMORI OLYMPUS CO., LTD. Kuroishi Site | Japan | A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures. |
| Nov 5, 2025 | B & D Dental Corp. | United States | Process validation activities and results have not been documented. |
| Nov 5, 2025 | SHANGHAI YOUWEN MEDICAL TECHNOLOGY CO LTD | China | Process validation activities and results have not been documented and approved. |
| Oct 30, 2025 | Flextronics America LLC | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Oct 29, 2025 | Supreme Screw Products, Inc. | United States | Process validation activities and results have not been documented. |
| Oct 24, 2025 | PADCO HOLDING COMPANY, LLC | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures. |
| Oct 23, 2025 | Amphenol DC Electronics Inc. | United States | Process validation activities have not been documented. |
| Oct 23, 2025 | Sheffield Precision Medical Limited | United Kingdom | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Oct 17, 2025 | Resonance Technology Inc | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures. |
| Oct 16, 2025 | Riverside Medical Packaging Company Ltd | United Kingdom | Process validation activities and results have not been adequately documented and adequately approved. |
| Sep 25, 2025 | ARCH Medical Solutions - Elmhurst | United States | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
| Sep 25, 2025 | Sterigenics UK Limited | United Kingdom | A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures. |
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