21 CFR 114.80(b) citations
FDA investigators cited 21 CFR 114.80(b) 551 times at 473 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 18, 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 |
|---|---|
| 2026 | 24 |
| 2025 | 39 |
| 2024 | 36 |
| 2023 | 29 |
| 2022 | 6 |
| 2021 | 4 |
| 2020 | 13 |
| 2019 | 27 |
| 2018 | 35 |
| 2017 | 38 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 18, 2026 | La Cuisine Provencale SASU | France | Each container is not marked with an identifying code specifying the establishment where the product was packed. |
| Aug 31, 2026 | Dongseo Wellbeing Corporation | Korea (the Republic of) | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period. |
| Aug 25, 2026 | RC Farms | United States | Each container is not marked with an identifying code specifying the year and date. |
| Aug 18, 2026 | Beth's Farm Kitchen LLC | United States | Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein. |
| Jul 28, 2026 | TAIZHOU JINSHA FOODS CO., LTD. | China | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period. |
| Jul 16, 2026 | Ove Water Services, Inc. | United States | Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein. |
| Jun 18, 2026 | Torii Foods Corporation | Japan | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period. |
| Jun 12, 2026 | Nikken Medical Corporation | Japan | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year and date. |
| Jun 5, 2026 | Powerful Health Food Co., Ltd. | Japan | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year and date. |
| Jun 3, 2026 | Select Juice, LLC | United States | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period. |
| May 26, 2026 | G S E FOOD ENTERPRISES LLC | United States | The packing period is not changed often enough to enable ready identification of lots during sale and distribution |
| Apr 14, 2026 | Stauffer's Country Kitchen LLC | United States | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period. |
| Apr 2, 2026 | Maryland Packaging Ltd | United States | Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein. |
| Mar 24, 2026 | Dona Janna S.A.S. Corporation | Ecuador | Each container is not marked with an identifying code specifying the product contained therein and packing period. |
| Mar 16, 2026 | Stuart's Cajun Pickles II. LLC | United States | Each container is not marked with an identifying code permanently visible to the naked eye. |
| Mar 16, 2026 | Stuart's Cajun Pickles II. LLC | United States | Each container is not marked with an identifying code specifying the year, date and packing period. |
| Mar 3, 2026 | Cloud Concepts LLC | United States | Each container is not marked with an identifying code specifying the establishment where the product was packed and year. |
| Feb 20, 2026 | Pooja Food Products | India | Each container is not marked with an identifying code permanently visible to the naked eye. |
| Nov 13, 2025 | BIO ORTO SOCIETA' COOPERATIVA AGRICOLA | Italy | Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein. |
| Nov 6, 2025 | Granda Tradizioni SRL | Italy | Each container is not marked with an identifying code specifying the establishment where the product was packed. |
| Nov 3, 2025 | Oliveri S.R.L. | Italy | Each container is not marked with an identifying code specifying the establishment where the product was packed. |
| Oct 31, 2025 | AGNONI SRL | Italy | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year, date and packing period. |
| Oct 29, 2025 | Frantoio Oleario Quattrociocchi Americo | Italy | Each container is not marked with an identifying code specifying the establishment where the product was packed, product contained therein, year and date. |
| Oct 28, 2025 | Carma S.R.L. | Italy | Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein. |
| Sep 24, 2025 | Namias Of Arizona, Inc. | United States | Each container is not marked with an identifying code specifying the establishment where the product was packed and product contained therein. |
Search more
Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.