21 CFR 1.506(b) citations
FDA investigators cited 21 CFR 1.506(b) 695 times at 625 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 | 116 |
| 2025 | 119 |
| 2024 | 77 |
| 2023 | 97 |
| 2022 | 137 |
| 2021 | 77 |
| 2020 | 40 |
| 2019 | 15 |
| 2018 | 7 |
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 establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Oct 16, 2026 | Blue Water USA, Inc. | United States | You did not follow your written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Sep 14, 2026 | FORTUNA RESOURCES INC | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 27, 2026 | Eiwa America, Inc. | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 25, 2026 | BRAVO FOODS USA INC | United States | You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 20, 2026 | DRISCOLL FOOD NJ | United States | You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 20, 2026 | SUNSTAR67 | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 6, 2026 | A&C Produce LLC | United States | You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 6, 2026 | BROWN-FORMAN CORPORATION | United States | You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 4, 2026 | KARINE & JEFF INC | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Aug 3, 2026 | Ferrara Candy Company | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 30, 2026 | Tang's Family Corporation | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 29, 2026 | FMS Fresh Produce Inc. | United States | You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 29, 2026 | GREEN BOY GROUP | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 23, 2026 | AR1 GROUP INC | United States | You did not follow your written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 23, 2026 | Distribuidora Jazmin LLC | United States | You did not follow your written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 23, 2026 | Distribuidora Jazmin LLC | United States | You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 23, 2026 | Importaciones La Bufa LLC | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 20, 2026 | CERES GOURMET LLC | United States | You did not follow your written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 16, 2026 | Tivoli Sweets America Inc. | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 15, 2026 | ART MX, LLC | United States | You did not follow your written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 14, 2026 | CANTABRIC SEAFOOD DISTRIBUTORS, INC | United States | You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 1, 2026 | Gourmet Imports LP | United States | You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jul 1, 2026 | Gourmet Imports LP | United States | You did not follow your written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
| Jun 29, 2026 | Alzar Distributions Inc | United States | You did not follow your written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import. |
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