21 CFR 820.50(a) citations
FDA investigators cited 21 CFR 820.50(a) 396 times at 369 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jan 13, 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 | 25 |
| 2024 | 20 |
| 2023 | 25 |
| 2022 | 17 |
| 2021 | 6 |
| 2020 | 9 |
| 2019 | 13 |
| 2018 | 22 |
| 2017 | 21 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jan 13, 2026 | Pleural Dynamics, Inc. | United States | Requirements that must be met by suppliers have not been adequately established. |
| Dec 18, 2025 | My Medical Store LLC | United States | Requirements that must be met by suppliers have not been adequately established. |
| Dec 12, 2025 | NeuroCareAI, Inc. | United States | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| Nov 25, 2025 | Avokaid, LLC | United States | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| Nov 4, 2025 | Tarmac Products, Inc. | United States | Requirements that must be met by suppliers and consultants have not been adequately established. |
| Sep 26, 2025 | G3 Medical | United States | Requirements that must be met by suppliers and contractors have not been adequately established. |
| Sep 11, 2025 | Diversified Healthcare Development LLC | United States | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| Aug 21, 2025 | Tri-Anim Health Services, Inc. | United States | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| Aug 19, 2025 | Diasol, Inc | United States | Requirements that must be met by contractors and consultants have not been adequately established. |
| Aug 7, 2025 | Magic Science Supply LLC | United States | Requirements that must be met by suppliers and consultants have not been adequately established. |
| Aug 5, 2025 | Carroll-Baccari Inc | United States | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| Aug 1, 2025 | Autocam Medical Devices, LLC. | United States | Requirements that must be met by suppliers have not been adequately established. |
| Jul 30, 2025 | Serim Research Corporation | United States | Requirements that must be met by suppliers have not been adequately established. |
| Jul 25, 2025 | Keystone Industries | United States | Requirements that must be met by suppliers have not been adequately established. |
| Jul 17, 2025 | Caragh Precision | Ireland | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| Jul 16, 2025 | GWR Medical, Inc. | United States | Requirements that must be met by suppliers have not been adequately established. |
| Jun 27, 2025 | NIMBLEHEART, INC | United States | Requirements that must be met by suppliers, contractors and consultants have not been established. |
| May 30, 2025 | CMI Health, Inc. | United States | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| May 27, 2025 | SpaceBander Corporation | United States | Requirements that must be met by suppliers and contractors have not been established. |
| May 8, 2025 | Aunt Flow Corp | United States | Requirements that must be met by suppliers, contractors and consultants have not been adequately established. |
| Apr 16, 2025 | The Richline Group Inc | United States | Requirements that must be met by suppliers and consultants have not been adequately established. |
| Apr 15, 2025 | ZOLL Medical Corporation | United States | Requirements that must be met by suppliers have not been established. |
| Mar 20, 2025 | MEDICREATIONS LLC | United States | Requirements that must be met by suppliers have not been adequately established. |
| Feb 20, 2025 | CLER VISION INC | United States | Requirements that must be met by suppliers have not been adequately established. |
| Feb 20, 2025 | Titan Implants, Inc | United States | Requirements that must be met by suppliers and consultants have not been adequately established. |
Search more
Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.