21 CFR 820.70(c) citations
FDA investigators cited 21 CFR 820.70(c) 512 times at 426 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 8, 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 | 5 |
| 2025 | 32 |
| 2024 | 20 |
| 2023 | 24 |
| 2022 | 15 |
| 2021 | 8 |
| 2020 | 26 |
| 2019 | 22 |
| 2018 | 41 |
| 2017 | 34 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jan 8, 2026 | J Sterling Industries, LLC | United States | Procedures to control environmental conditions have not been adequately established. |
| Dec 15, 2025 | MEDTRONIC GRAND RAPIDS | United States | Procedures to control environmental conditions have not been adequately established. |
| Dec 10, 2025 | Next Medical Products Company, LLC | United States | Procedures to control environmental conditions have not been adequately established. |
| Nov 21, 2025 | 3D Diagnostix Inc. | United States | Procedures to control environmental conditions have not been adequately established. |
| Oct 16, 2025 | Riverside Medical Packaging Company Ltd | United Kingdom | Procedures to control environmental conditions have not been adequately established. |
| Sep 12, 2025 | Rms Company | United States | Procedures to control environmental conditions have not been adequately established. |
| Sep 5, 2025 | Keter Canada, Inc. | Canada | Procedures to control environmental conditions have not been established. |
| Aug 28, 2025 | Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | China | Procedures to control environmental conditions have not been adequately established. |
| Aug 11, 2025 | Nexxt Spine, LLC | United States | Procedures to control environmental conditions have not been established. |
| Jul 28, 2025 | Omnia Medical | United States | Procedures to control environmental conditions have not been established. |
| Jul 25, 2025 | Exactech Sarasota, Inc. | United States | Procedures to control environmental conditions have not been adequately established. |
| Jul 17, 2025 | Custom Wire Technologies, Inc. | United States | Procedures to control environmental conditions have not been adequately established. |
| Jul 3, 2025 | Hubei Qianjiang Kingphar Medical Material Co. Ltd. | China | Procedures to control environmental conditions have not been adequately established. |
| Jun 26, 2025 | PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. | China | Procedures to control environmental conditions have not been adequately established. |
| Jun 24, 2025 | Fermatex Vascular Technologies | United States | Procedures to control environmental conditions have not been adequately established. |
| Jun 12, 2025 | RENISHAW MAYFIELD | France | Procedures to control environmental conditions have not been established. |
| Jun 6, 2025 | Preservation Solutions, Inc. | United States | Procedures to control environmental conditions have not been adequately established. |
| Jun 4, 2025 | Cook Incorporated | United States | Procedures to control environmental conditions have not been adequately established. |
| May 22, 2025 | Sabre Medical Pty. Ltd. | Australia | Procedures to control environmental conditions have not been adequately established. |
| May 16, 2025 | SALUDA MEDICAL PTY. LTD. | Australia | Procedures to control environmental conditions have not been adequately established. |
| May 12, 2025 | Mid South Precision, Inc. | United States | Procedures to control environmental conditions have not been adequately established. |
| Apr 23, 2025 | Quality Aspirators, Inc | United States | Procedures to control environmental conditions have not been established. |
| Apr 16, 2025 | LeMaitre Vascular, Inc. | United States | Procedures to control environmental conditions have not been adequately established. |
| Apr 10, 2025 | HERSILL, S.L. | Spain | Procedures to control environmental conditions have not been adequately established. |
| Mar 21, 2025 | MP Biomedicals Asia Pacific Pte Ltd | Singapore | Procedures to control environmental conditions have not been adequately established. |
Search more
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