21 CFR 117.40 citations
FDA investigators cited 21 CFR 117.40 1,140 times at 1,036 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 7, 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 | 121 |
| 2025 | 114 |
| 2024 | 133 |
| 2023 | 140 |
| 2022 | 112 |
| 2021 | 72 |
| 2020 | 69 |
| 2019 | 165 |
| 2018 | 159 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Oct 7, 2026 | Tam An 2, Inc. (Formerly Rach Gia, Inc.) | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Sep 25, 2026 | MADEMOISELLE COLETTE INC | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Sep 23, 2026 | Aurora Products, Inc. | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Sep 17, 2026 | Del Monte Fresh Produce N.A. | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Sep 11, 2026 | Broad Ripple Chip Co. | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Sep 10, 2026 | P&M Group, Inc. | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Sep 2, 2026 | Gate Gourmet, Inc #566 | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against allergen cross-contact and contamination. |
| Aug 31, 2026 | An Xuyen Bakery, Inc. | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 31, 2026 | Dae Won Food USA Inc. | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 26, 2026 | Jetfinity Inc. | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 21, 2026 | BEER NUTS INC | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 21, 2026 | Sunshine Peanut Company | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against allergen cross-contact. |
| Aug 19, 2026 | Air Culinaire - Chicago | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against. |
| Aug 18, 2026 | Beth's Farm Kitchen LLC | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 17, 2026 | Prince Bakery Inc | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 14, 2026 | Bonghwa Cheongryangsan Kimchi Agricultural Co., Ltd. | Korea (the Republic of) | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 11, 2026 | Greenpia Co., Ltd. | Korea (the Republic of) | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Aug 5, 2026 | SIB, Inc. D.B.A. Scholars Inn Bakehouse | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against allergen cross-contact and contamination. |
| Jul 28, 2026 | PFE , LLC | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Jul 28, 2026 | TAIZHOU JINSHA FOODS CO., LTD. | China | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Jul 24, 2026 | Bud Antle, LLC - Bessemer City Location | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Jul 23, 2026 | Royal Fresh Cuts, LLC | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Jul 16, 2026 | La Gloria Foods Corp | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Jul 9, 2026 | Mavi S.R.L. | Italy | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
| Jul 7, 2026 | Farmers Market Fort Worth, Inc | United States | Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination. |
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