21 CFR 111.255(b) citations
FDA investigators cited 21 CFR 111.255(b) 590 times at 425 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 30, 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 | 23 |
| 2025 | 14 |
| 2024 | 44 |
| 2023 | 38 |
| 2022 | 36 |
| 2021 | 20 |
| 2020 | 20 |
| 2019 | 47 |
| 2018 | 44 |
| 2017 | 47 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 30, 2026 | Wand Packaging Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Aug 28, 2026 | Yep Strength | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Aug 21, 2026 | Balassa Laboratories, Inc | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Jul 21, 2026 | Naturecom Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Jul 16, 2026 | Synchpack Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Jul 14, 2026 | Enrinity Supplements, Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Jul 14, 2026 | Krakatoa Inc (FL) | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Jun 25, 2026 | FAME Health Labs LLC | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Jun 10, 2026 | E2E PHARMA LLC | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| May 18, 2026 | Price Pharmaceuticals, LLC D.B.A. Just Move Supplements | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| May 15, 2026 | Toffee Up Corp | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Apr 29, 2026 | Aloe Queen, Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Apr 27, 2026 | Enterprise Mac, LLC | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Apr 17, 2026 | Neurogan, Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Mar 20, 2026 | Biogenic Minerals Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Mar 16, 2026 | Albanese Confectionery Group, Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Feb 26, 2026 | Ambaya Gold Health Products, LLC | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Feb 18, 2026 | Spartan Enterprises Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Feb 13, 2026 | G & G Food Supplies Limited | United Kingdom | Your batch production record did not include complete information relating to the production and control of each batch. |
| Feb 5, 2026 | Hawaiian Islands Trading Company LLC | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Jan 15, 2026 | Focus Nutrition | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Nov 7, 2025 | HoneyCombs Industries, LLC | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Nov 7, 2025 | Optiwize Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Sep 25, 2025 | Virun, Inc. | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
| Aug 29, 2025 | Pharma Works LLC | United States | Your batch production record did not include complete information relating to the production and control of each batch. |
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