21 CFR 123.11(b) citations
FDA investigators cited 21 CFR 123.11(b) 4,492 times at 2,726 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 9, 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 |
|---|---|
| 2027 | 1 |
| 2026 | 132 |
| 2025 | 114 |
| 2024 | 96 |
| 2023 | 135 |
| 2022 | 78 |
| 2021 | 60 |
| 2020 | 91 |
| 2019 | 227 |
| 2018 | 221 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Oct 9, 2026 | Usarg, Inc | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including. |
| Sep 11, 2026 | Ingardia Bros. Produce, Inc. | United States | Your sanitation control records do not accurately document the conditions or practices observed at your firm. |
| Sep 11, 2026 | Ingardia Bros. Produce, Inc. | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or… |
| Sep 4, 2026 | Aparna Marine Exports | India | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces… |
| Aug 26, 2026 | CNF CO., LTD | Korea (the Republic of) | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces… |
| Aug 20, 2026 | Stagnaro Brothers Seafood Inc. | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces… |
| Aug 19, 2026 | Local Bounty | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary… |
| Aug 18, 2026 | BIEN QUYNH JOINT STOCK COMPANY | Vietnam | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or… |
| Aug 18, 2026 | F-ONE GLOBAL FOODS COMPANY LIMITED | Vietnam | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or… |
| Aug 18, 2026 | Sovereign Seafoods, Inc. | United States | Your sanitation control records do not accurately document the conditions or practices observed at your firm. |
| Aug 12, 2026 | Hamasui Co., Ltd. | Japan | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including proper labeling, storage and use of toxic chemicals. |
| Aug 11, 2026 | La Bakerie Inc | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including. |
| Aug 6, 2026 | Fog River Fresh, Inc. | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces… |
| Aug 5, 2026 | Marutoku Suisan Co., Ltd., Wakayama Factory | Japan | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or… |
| Aug 4, 2026 | Trang Thuy Seafood Company Limited | Vietnam | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary… |
| Jul 24, 2026 | Ocomar Enterprises | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary… |
| Jul 23, 2026 | Los Olivos, LTD. | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including maintenance of hand washing, hand sanitizing, and toilet… |
| Jul 22, 2026 | NAGASAKI TAKARA SYOKUHIN Co., Ltd. KYOUDOMARI FACTORY | Japan | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including. |
| Jul 21, 2026 | Joseph's Industrial Catering, Corp. | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces… |
| Jul 16, 2026 | Wayne Distribution Center, LLC | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces and… |
| Jul 15, 2026 | Catsmo, LLC | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary… |
| Jul 7, 2026 | Montauk Seafood Co. Inc. | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or… |
| Jul 6, 2026 | MARUICHI FOOD CO., LTD. | Japan | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including protection of food, food packaging material, and food… |
| Jul 1, 2026 | Pine State Seafood | United States | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including protection of food, food packaging material, and food… |
| Jun 29, 2026 | Hai Thanh Food Co., Ltd. | Vietnam | You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including protection of food, food packaging material, and food… |
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