21 CFR 111.475(b)(1) citations
FDA investigators cited 21 CFR 111.475(b)(1) 314 times at 290 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Apr 26, 2024. 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 |
|---|---|
| 2024 | 10 |
| 2023 | 13 |
| 2022 | 19 |
| 2021 | 5 |
| 2020 | 7 |
| 2019 | 11 |
| 2018 | 28 |
| 2017 | 36 |
| 2016 | 27 |
| 2015 | 13 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Apr 26, 2024 | Cisne Enterprises Inc. | United States | You did not make and keep written procedures for holding and distributing operations. |
| Apr 11, 2024 | Nature's Innovation, Inc. | United States | You did not make and keep written procedures for holding and distributing operations. |
| Mar 22, 2024 | Bio Herbal USA | United States | You did not make and keep written procedures for holding and distributing operations. |
| Mar 22, 2024 | Weleda Inc | United States | You did not make and keep written procedures for holding and distributing operations. |
| Feb 29, 2024 | Green Sun Products, LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jan 31, 2024 | Talisman LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jan 29, 2024 | Jiro Group, Inc. | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jan 23, 2024 | GO Life Corporation | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jan 11, 2024 | US Times Technology Inc | United States | You did not make and keep written procedures for holding and distributing operations. |
| Nov 14, 2023 | Txsyn Int. LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jul 25, 2023 | Aphrodite's Apothecary, LLC. | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jul 18, 2023 | Lipo Naturals, LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jun 21, 2023 | G&C Pharmaceuticals, Inc. | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jun 14, 2023 | MDS Fulfillment, Inc. | United States | You did not make and keep written procedures for holding and distributing operations. |
| Mar 28, 2023 | E&D Herbs Medicine Natural Product, LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Mar 22, 2023 | Crane Herb Company | United States | You did not make and keep written procedures for holding and distributing operations. |
| Mar 14, 2023 | Vita 360, LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Feb 1, 2023 | Healthtex Distributors, LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jan 30, 2023 | Herbal Essentials Inc. | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jan 24, 2023 | CLASSICAL INSIGHTS LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Jan 19, 2023 | Sound Healing Arts, PC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Nov 4, 2022 | Walkabout Health Products | United States | You did not make and keep written procedures for holding and distributing operations. |
| Oct 14, 2022 | UNIVERSAL HERB USA LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Sep 21, 2022 | Anabolic Science Labs, LLC | United States | You did not make and keep written procedures for holding and distributing operations. |
| Sep 14, 2022 | The Herbalist- Retail | United States | You did not make and keep written procedures for holding and distributing operations. |
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