21 CFR 111.70(b)(2) citations
FDA investigators cited 21 CFR 111.70(b)(2) 513 times at 397 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 25, 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 | 58 |
| 2023 | 46 |
| 2022 | 44 |
| 2021 | 28 |
| 2020 | 28 |
| 2019 | 37 |
| 2018 | 37 |
| 2017 | 43 |
| 2016 | 34 |
| 2015 | 25 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jul 25, 2024 | Hyalogic LLC | United States | You did not establish component specifications for purity and strength. |
| Jul 19, 2024 | PRC, Inc | United States | You did not establish component specifications for purity, strength and composition. |
| Jul 17, 2024 | Alfa Vitamins Laboratories Inc. | United States | You did not establish component specifications for strength and composition. |
| Jul 17, 2024 | Dert Inc. | United States | You did not establish component specifications for purity, strength and composition. |
| Jul 12, 2024 | Country Life, LLC | United States | You did not establish component specifications for purity, strength and composition. |
| Jul 11, 2024 | Greenland Inc | United States | You did not establish component specifications for purity, strength and composition. |
| Jul 10, 2024 | Al Global, Inc. | United States | You did not establish component specifications for purity, strength and composition. |
| Jun 25, 2024 | Aqua Nutraceuticals LLC | United States | You did not establish component specifications for purity, strength and composition. |
| Jun 14, 2024 | Pinnacle Labs International, Inc. | United States | You did not establish component specifications for purity, strength and composition. |
| Jun 14, 2024 | US FOOD MANUFACTURING | United States | You did not establish component specifications for purity, strength and composition. |
| Jun 13, 2024 | Penn Herb Company, Ltd. | United States | You did not establish component specifications for purity, strength and composition. |
| Jun 7, 2024 | Mcclarry Innovation LLC | United States | You did not establish component specifications for purity, strength and composition. |
| May 31, 2024 | TCI (TAIWAN) S5 PABP BRANCH | Taiwan | You did not establish component specifications for purity, strength and composition. |
| May 28, 2024 | I AM WELL HOLISTIC INC | United States | You did not establish component specifications for purity, strength and composition. |
| May 28, 2024 | REVE PHARMA | India | You did not establish component specifications for strength. |
| May 24, 2024 | General Research Laboratories | United States | You did not establish component specifications for purity, strength and composition. |
| May 24, 2024 | Himalaya Wellness Company | India | You did not establish component specifications for strength. |
| May 22, 2024 | Florida Nutrition Inc. | United States | You did not establish component specifications for purity, strength and composition. |
| May 17, 2024 | FCC Horiuchi Co., Ltd. | Japan | You did not establish component specifications for purity, strength and composition. |
| May 16, 2024 | Dr Ma's Laboratories, Inc. | Canada | You did not establish component specifications for purity, strength and composition. |
| May 13, 2024 | North American Herb And Spice Co. LTD, LLC | United States | You did not establish component specifications for purity. |
| May 10, 2024 | Pro Line Nutrition LTD. | Canada | You did not establish component specifications for purity, strength and composition. |
| Apr 26, 2024 | BodyBio Inc. | United States | You did not establish component specifications for purity and strength. |
| Apr 22, 2024 | BF Suma Pharmaceuticals, Inc. | United States | You did not establish component specifications for purity, strength and composition. |
| Apr 22, 2024 | Enrinity Supplements, Inc. | United States | You did not establish component specifications for purity, strength and composition. |
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