21 CFR 117.135(c)(3) citations
FDA investigators cited 21 CFR 117.135(c)(3) 440 times at 401 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 24, 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 | 84 |
| 2025 | 84 |
| 2024 | 54 |
| 2023 | 53 |
| 2022 | 43 |
| 2021 | 15 |
| 2020 | 30 |
| 2019 | 42 |
| 2018 | 24 |
| 2017 | 11 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 24, 2026 | McCormick France | France | Your written sanitation preventive control, monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Sep 17, 2026 | Krispy Kreme Doughnut Corporation | United States | Your written sanitation preventive control, monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Sep 15, 2026 | NuVue Foods Inc. | United States | Your written sanitation verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Sep 9, 2026 | GOHYANG FOOD CO., LTD. | Korea (the Republic of) | Your written sanitation preventive control, monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Sep 8, 2026 | NDR Liuzzi, LLC | United States | Your written sanitation preventive control and monitoring procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Sep 3, 2026 | HYOSUNG FOOD CO. LTD. | Korea (the Republic of) | Your written sanitation monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Sep 2, 2026 | Kanro Inc. | Japan | Your written sanitation verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Aug 21, 2026 | K.Minamoto Co., Ltd. | Japan | Your written sanitation preventive control procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Aug 14, 2026 | Hannah International Foods, Inc. | United States | Your written sanitation monitoring procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Aug 14, 2026 | Tampico Spice Company Inc | United States | Your written sanitation preventive control, monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 24, 2026 | Jagpreet Enterprises, LLC. | United States | Your written sanitation preventive control procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 23, 2026 | Royal Fresh Cuts, LLC | United States | Your written sanitation preventive control procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 22, 2026 | El Matador Foods | United States | Your written sanitation verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 21, 2026 | Whakyung Co. | Korea (the Republic of) | Your written sanitation preventive control procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 20, 2026 | Land O Lakes, Inc. | United States | Your written sanitation preventive control, monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 16, 2026 | IL Mi Agricultural & Fisheries Co., Ltd. | Korea (the Republic of) | Your written sanitation monitoring procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 10, 2026 | La Orocovena Biscuit De PR, Inc. | United States | Your written sanitation preventive control and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 9, 2026 | Mary's Harvest Fresh Foods, Inc. | United States | Your written sanitation preventive control procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 7, 2026 | Farmers Market Fort Worth, Inc | United States | Your written sanitation preventive control and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jul 2, 2026 | Sweet Ann Cake, Inc. | United States | Your written sanitation verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jun 22, 2026 | GATE GOURMET, INC. | United States | Your written sanitation corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jun 18, 2026 | Industria Lechera De Puerto Rico, Inc. | United States | Your written sanitation monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jun 18, 2026 | Sirob Imports, Inc. | United States | Your written sanitation monitoring and corrective action procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| Jun 3, 2026 | Dream Land, Inc. | United States | Your written sanitation monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
| May 29, 2026 | Boichik Bagels, Inc. | United States | Your written sanitation preventive control, monitoring, corrective action and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. |
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