21 CFR 820.181 citations
FDA investigators cited 21 CFR 820.181 795 times at 699 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Mar 3, 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 | 27 |
| 2024 | 26 |
| 2023 | 35 |
| 2022 | 24 |
| 2021 | 13 |
| 2020 | 29 |
| 2019 | 43 |
| 2018 | 58 |
| 2017 | 58 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Mar 3, 2026 | Medivis, Inc. | United States | A device master record has not been adequately maintained. |
| Jan 12, 2026 | ZIIP INC | United States | A device master record has not been maintained. |
| Dec 11, 2025 | Specialty Health Products CO, LLC | United States | A device master record has not been maintained. |
| Dec 3, 2025 | ASEPTIKITS, LLC | United States | A device master record has not been adequately maintained. |
| Nov 13, 2025 | Hakko Co., Ltd. | Japan | A device master record has not been adequately maintained. |
| Oct 22, 2025 | Lightwave | United States | A device master record has not been maintained. |
| Sep 19, 2025 | Tuxedo Imaging | United States | A device master record has not been maintained. |
| Aug 27, 2025 | Exactech, Inc. | United States | A device master record has not been adequately maintained. |
| Aug 20, 2025 | Pharmacaribe, LLC | United States | A device master record has not been adequately maintained. |
| Aug 19, 2025 | Diasol, Inc | United States | A device master record has not been adequately maintained. |
| Jul 18, 2025 | Microvapor Devices LLC | United States | A device master record has not been maintained. |
| Jun 12, 2025 | RENISHAW MAYFIELD | France | A device master record has not been adequately maintained. |
| Jun 2, 2025 | Syntron Bioresearch Inc | United States | A device master record has not been maintained. |
| May 16, 2025 | Blue Elephant Inc | United States | A device master record has not been maintained. |
| Apr 23, 2025 | Miach Orthopaedics | United States | A device master record has not been adequately maintained. |
| Apr 23, 2025 | R-Med Inc | United States | A device master record has not been adequately maintained. |
| Apr 16, 2025 | The Richline Group Inc | United States | A device master record has not been adequately maintained. |
| Apr 15, 2025 | Electromedical Technologies, Inc | United States | A device master record has not been adequately maintained. |
| Apr 7, 2025 | Neogen Corporation | United States | A device master record has not been adequately maintained. |
| Feb 26, 2025 | Instrumedical Technologies Inc | United States | A device master record has not been adequately maintained. |
| Feb 21, 2025 | Neosoma, Inc. | United States | A device master record has not been maintained. |
| Feb 20, 2025 | Arnold Tuber Industries, LLC | United States | A device master record has not been adequately maintained. |
| Feb 18, 2025 | MICROspecialties, LLC | United States | A device master record has not been adequately maintained. |
| Feb 4, 2025 | WillowWood Global Llc | United States | A device master record has not been maintained. |
| Jan 24, 2025 | Microlight Corporation Of America | United States | A device master record has not been adequately maintained. |
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