21 CFR 1.504(a) citations
FDA investigators cited 21 CFR 1.504(a) 606 times at 559 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 | 2 |
| 2026 | 71 |
| 2025 | 68 |
| 2024 | 66 |
| 2023 | 108 |
| 2022 | 107 |
| 2021 | 81 |
| 2020 | 48 |
| 2019 | 19 |
| 2018 | 23 |
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 have a written hazard analysis. |
| Oct 26, 2026 | Valdes Farm Inc | United States | You did not have a written hazard analysis. |
| Sep 14, 2026 | FORTUNA RESOURCES INC | United States | You did not have a written hazard analysis. |
| Aug 31, 2026 | Commodity Services International, Inc. | United States | You did not have a written hazard analysis. |
| Aug 31, 2026 | Gallia Imports LLC | United States | You did not have a written hazard analysis. |
| Aug 18, 2026 | Source One International | United States | You did not have a written hazard analysis. |
| Aug 7, 2026 | D. Coluccio & Sons Inc. | United States | You did not have a written hazard analysis. |
| Aug 6, 2026 | BROWN-FORMAN CORPORATION | United States | You did not have a written hazard analysis. |
| Aug 5, 2026 | Jorday Foods International LLC | United States | You did not have a written hazard analysis. |
| Aug 4, 2026 | KARINE & JEFF INC | United States | You did not have a written hazard analysis. |
| Jul 31, 2026 | Sasta Bazaar Inc. | United States | You did not have a written hazard analysis. |
| Jul 30, 2026 | NATURALLY PLUS USA, INC. | United States | You did not have a written hazard analysis. |
| Jul 29, 2026 | FMS Fresh Produce Inc. | United States | You did not have a written hazard analysis. |
| Jul 23, 2026 | Distribuidora Jazmin LLC | United States | You did not have a written hazard analysis. |
| Jul 23, 2026 | Importaciones La Bufa LLC | United States | You did not have a written hazard analysis. |
| Jul 17, 2026 | FRIENDS OF SAN LUCAS | United States | You did not have a written hazard analysis. |
| Jun 23, 2026 | MIZUBA Corporation | United States | You did not have a written hazard analysis. |
| Jun 15, 2026 | JOHNSON ASSOCIATED FRUIT CO LTD | United States | You did not have a written hazard analysis. |
| Jun 5, 2026 | PROCESSORS CO OP INC | United States | You did not have a written hazard analysis. |
| Jun 3, 2026 | US Commoditites, LLC | United States | You did not have a written hazard analysis. |
| May 29, 2026 | INDOUSA INC | United States | You did not have a written hazard analysis. |
| May 29, 2026 | Quality Casing Company, Inc. | United States | You did not have a written hazard analysis. |
| May 26, 2026 | GLOBAL HARVEST PRODUCE, LLC | United States | You did not have a written hazard analysis. |
| May 18, 2026 | Jinlifu USA Inc. | United States | You did not have a written hazard analysis. |
| May 18, 2026 | Pacific Golden Coast Trading Inc | United States | You did not have a written hazard analysis. |
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