21 CFR 820.50(a)(1) citations
FDA investigators cited 21 CFR 820.50(a)(1) 396 times at 362 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Apr 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 | 4 |
| 2025 | 6 |
| 2024 | 15 |
| 2023 | 32 |
| 2022 | 12 |
| 2021 | 3 |
| 2020 | 20 |
| 2019 | 27 |
| 2018 | 27 |
| 2017 | 32 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Apr 16, 2026 | Emerald Supply Inc | United States | Potential suppliers and contractors were not evaluated and selected based on their ability to meet specified requirements. |
| Jan 7, 2026 | Osseofuse International Inc. | United States | The evaluation of potential contractors was not documented. |
| Nov 12, 2025 | Banyan USA LLC | United States | The evaluation of potential suppliers was not documented. |
| Oct 29, 2025 | Supreme Screw Products, Inc. | United States | The evaluation of potential suppliers and contractors was not documented. |
| Apr 23, 2025 | Miach Orthopaedics | United States | The evaluation of potential suppliers and consultants was not documented. |
| Mar 14, 2025 | Vayuclear Inc | United States | The evaluation of potential suppliers and contractors was not documented. |
| Feb 14, 2025 | PRG Management LLC | United States | The evaluation of potential suppliers was not documented. |
| Dec 13, 2024 | Medshift | United States | The evaluation of potential suppliers, contractors and consultants was not documented. |
| Nov 6, 2024 | Ensitevascular LLC | United States | Potential suppliers, contractors and consultants were not evaluated and selected based on their ability to meet specified requirements. |
| Nov 4, 2024 | Danmar Products, Inc. | United States | The evaluation of potential suppliers was not documented. |
| Aug 8, 2024 | Qapel Medical Inc. | United States | Potential suppliers, contractors and consultants were not evaluated and selected based on their ability to meet specified requirements. |
| Aug 7, 2024 | Starr Frame LLC | United States | The evaluation of potential contractors and consultants was not documented. |
| Jul 25, 2024 | Vocare, Inc. | United States | Potential suppliers were not evaluated and selected based on their ability to meet specified requirements. |
| May 31, 2024 | AFP Manufacturing | United States | Potential suppliers and contractors were not evaluated based on their ability to meet specified requirements. |
| May 17, 2024 | Cardio Flow, Inc. | United States | The evaluation of potential suppliers was not documented. |
| Apr 25, 2024 | WISSNER-BOSSERHOFF GMBH | Germany | Potential suppliers and contractors were not evaluated and selected based on their ability to meet specified requirements. |
| Apr 17, 2024 | Retivue Llc | United States | The evaluation of potential suppliers and contractors was not documented. |
| Mar 26, 2024 | Transdermal Cap Inc. | United States | Potential suppliers were not evaluated and selected based on their ability to meet specified requirements. |
| Mar 21, 2024 | Sentiar Inc | United States | Potential suppliers were not evaluated based on their ability to meet specified requirements. |
| Jan 31, 2024 | Bound Tree Medical, LLC | United States | Potential suppliers, contractors and consultants were not evaluated and selected based on their ability to meet specified requirements. |
| Dec 21, 2023 | Shikani Medical, LLC | United States | Potential suppliers, contractors and consultants were not evaluated and selected based on their ability to meet specified requirements. |
| Dec 8, 2023 | Roche Molecular Systems, Inc. | United States | Potential suppliers were not evaluated and selected based on their ability to meet specified requirements. |
| Oct 31, 2023 | CFS Dental, Inc | United States | Potential suppliers and contractors were not evaluated based on their ability to meet specified requirements. |
| Oct 18, 2023 | 3-D Matrix, Inc. | United States | The evaluation of potential suppliers was not documented. |
| Oct 2, 2023 | Synovo Production, Inc. | United States | Potential suppliers were not evaluated based on their ability to meet specified requirements. |
Search more
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