21 CFR 117.4 citations
FDA investigators cited 21 CFR 117.4 540 times at 491 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 5, 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 | 54 |
| 2025 | 59 |
| 2024 | 53 |
| 2023 | 44 |
| 2022 | 63 |
| 2021 | 40 |
| 2020 | 54 |
| 2019 | 105 |
| 2018 | 59 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Oct 5, 2026 | Albert's Organics, Inc. | United States | You did not ensure individuals were qualified to perform their assigned duties. |
| Aug 28, 2026 | Chef K, Inc. | United States | You did not have records documenting food hygiene and food safety training. |
| Aug 21, 2026 | Wako Inflight Service Inc | United States | You did not ensure individuals were qualified to perform their assigned duties. |
| Aug 19, 2026 | Punjab Trading Inc | United States | You did not have records documenting food hygiene and food safety training. |
| Jul 28, 2026 | Bakery Espiga Deora, Inc. | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Jul 24, 2026 | Harvester Foods Corp. | United States | You did not have records documenting food hygiene and food safety training. |
| Jul 8, 2026 | M & P Food Productions, Ltd. | United States | You did not have records documenting food hygiene and food safety training. |
| Jul 3, 2026 | JIYA ORGANIC INC | India | You did not ensure individuals were qualified to perform their assigned duties. |
| Jun 26, 2026 | TAMPASTA LIMITED LIABILITY COMPANY | United States | You did not have records documenting food hygiene and food safety training. |
| Jun 25, 2026 | Marine Frozen Foods Company LTD | Thailand | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Jun 25, 2026 | TPFN LLC | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Jun 25, 2026 | White Eagle Foods Mfg., LLC | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Jun 18, 2026 | Marquez Brothers International, Inc | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Jun 16, 2026 | Empresas Gutierrez Del Arroyo, Inc | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Jun 10, 2026 | CB Foods El Monte, Inc. | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Jun 2, 2026 | Penguin Marketing Corporation | United States | You did not have records documenting food hygiene and food safety training. |
| May 27, 2026 | Dumplin Shoppe Inc (The) | United States | You did not have records documenting food hygiene and food safety training. |
| May 22, 2026 | Refresqueria Estrella Inc. | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| May 21, 2026 | Leo's Elite Bakery, LLC | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| May 21, 2026 | T & S Produce Inc. | United States | You did not have records documenting food hygiene and food safety training. |
| May 20, 2026 | Imperial Nougat Company | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| May 19, 2026 | L & C Cook Specialty Foods, Inc. | United States | You did not have records documenting food hygiene and food safety training. |
| May 13, 2026 | De Dios's Ice Pops II LLC | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| May 11, 2026 | TJ Processors 3 LLC | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
| Apr 29, 2026 | Bass Pro Shops | United States | You did not ensure individuals were qualified to perform their assigned duties and have records documenting food hygiene and food safety training. |
Search more
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