21 CFR 820.90(b)(2) citations
FDA investigators cited 21 CFR 820.90(b)(2) 429 times at 388 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Nov 6, 2025. 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 | 2 |
| 2025 | 12 |
| 2024 | 21 |
| 2023 | 23 |
| 2022 | 13 |
| 2021 | 7 |
| 2020 | 15 |
| 2019 | 29 |
| 2018 | 32 |
| 2017 | 33 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Nov 6, 2025 | Turbett Surgical, Inc. | United States | Procedures for rework of nonconforming product have not been established. |
| Oct 24, 2025 | PADCO HOLDING COMPANY, LLC | United States | Procedures for rework of nonconforming product have not been established. |
| Sep 11, 2025 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | China | Procedures for rework of nonconforming product have not been adequately established. |
| Aug 13, 2025 | Medical Instrument Development Laboratories, Inc. | United States | Procedures for rework of nonconforming product have not been established. |
| May 29, 2025 | Uscom Limited | Australia | Rework and reevaluation activities have not been fully documented in the device history record. |
| May 23, 2025 | Somnomed Inc | United States | Procedures for rework of nonconforming product have not been established. |
| Mar 7, 2025 | Aeon Biotherapeutics Corp. | Taiwan | Procedures for rework of nonconforming product have not been adequately established. |
| Feb 21, 2025 | Rohrer Aesthetics Inc. | United States | Procedures for rework of nonconforming product have not been established. |
| Feb 7, 2025 | Lazurite Inc. | United States | Procedures for rework of nonconforming product have not been adequately established. |
| Feb 4, 2025 | WillowWood Global Llc | United States | Procedures for rework of nonconforming product have not been established. |
| Jan 29, 2025 | AEI Technologies, Inc | United States | Procedures for rework of nonconforming product have not been adequately established. |
| Dec 20, 2024 | RESET TECHNOLOGY CORPORATION | United States | Procedures for rework of nonconforming product have not been established. |
| Dec 19, 2024 | Specialty Vision Llc | United States | Procedures for rework of nonconforming product have not been adequately established. |
| Nov 26, 2024 | Noah Medical Corporation | United States | Procedures for rework of nonconforming product have not been adequately established. |
| Sep 20, 2024 | Charmcare Co. Ltd | Korea (the Republic of) | Procedures for rework of nonconforming product have not been adequately established. |
| Aug 22, 2024 | General Meditech Inc | China | Rework and reevaluation activities have not been fully documented in the device history record. |
| Aug 1, 2024 | Rochal Technologies | United States | Procedures for rework of nonconforming product have not been adequately established. |
| Jul 11, 2024 | Hocoma AG | Switzerland | Procedures for rework of nonconforming product have not been adequately established. |
| Jul 11, 2024 | KONO SEISAKUSHO | Japan | Procedures for rework of nonconforming product have not been adequately established. |
| Jul 2, 2024 | The Morel Company, LLC | United States | Procedures for rework of nonconforming product have not been adequately established. |
| Apr 26, 2024 | Mid South Precision, Inc. | United States | Procedures for rework of nonconforming product have not been adequately established. |
| Apr 25, 2024 | PolarSeal Tapes And Conversions, Ltd. | United Kingdom | Documentation of rework and reevaluation activities does not include a determination of whether there has been any adverse effect from rework upon the product. |
| Apr 24, 2024 | Morgan Innovation & Technology Ltd | United Kingdom | Rework and reevaluation activities have not been fully documented in the device history record. |
| Apr 11, 2024 | AeroBiotix USA | United States | Rework and reevaluation activities have not been documented in the device history record. |
| Apr 11, 2024 | Cogmedix, Inc. | United States | Procedures for rework of nonconforming product have not been adequately established. |
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