21 CFR 1.505(b) citations
FDA investigators cited 21 CFR 1.505(b) 436 times at 408 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 27, 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 | 43 |
| 2025 | 35 |
| 2024 | 37 |
| 2023 | 82 |
| 2022 | 67 |
| 2021 | 71 |
| 2020 | 56 |
| 2019 | 26 |
| 2018 | 11 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Oct 27, 2026 | Bangkok Bangkok Import Export Inc. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Aug 25, 2026 | BRAVO FOODS USA INC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Aug 17, 2026 | FRESH FLAVOR INTERNATIONAL INC. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jul 29, 2026 | FMS Fresh Produce Inc. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jul 8, 2026 | Big Green (USA) Inc. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jun 26, 2026 | D G EXPRESS TRANSPORT LLC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jun 25, 2026 | VP Fresh Produce, LLC. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jun 23, 2026 | MIZUBA Corporation | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jun 10, 2026 | C&D INTERNATIONAL FISHERY INC. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jun 9, 2026 | Mexicorp LLC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jun 9, 2026 | SPECNOVA LLC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Jun 1, 2026 | Kepix, Corp. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| May 28, 2026 | Concord Feed & Fuel, Inc. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| May 19, 2026 | CTI Foods Kentucky, LLC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| May 14, 2026 | CAKE DEVELOPMENT GROUP INC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| May 13, 2026 | AUTHENTIC FOOD INC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| May 12, 2026 | OM FOODS INC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| May 5, 2026 | Peakopia Produce | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Apr 30, 2026 | JLS Foods International | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Apr 28, 2026 | Mex Flores Produce Co., Inc. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Apr 24, 2026 | Family Foods International Inc. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Apr 17, 2026 | Schuster Products, LLC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Apr 15, 2026 | ONE SOURCE TRADING, INC | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Apr 8, 2026 | Yihai US Food Inc | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
| Mar 26, 2026 | TOCUMEN PRODUCE, INC. | United States | You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another… |
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