21 CFR 111.75(c) citations
FDA investigators cited 21 CFR 111.75(c) 542 times at 407 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 23, 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 | 46 |
| 2025 | 28 |
| 2024 | 24 |
| 2023 | 13 |
| 2022 | 24 |
| 2021 | 15 |
| 2020 | 16 |
| 2019 | 31 |
| 2018 | 41 |
| 2017 | 63 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 23, 2026 | Catalo Natural Health Science Inc. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Sep 16, 2026 | TAKA USA, INC. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration… |
| Aug 31, 2026 | GENVID LAB INC. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Aug 27, 2026 | RAPHA Health Network International, Inc. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Aug 21, 2026 | Drucker Labs, LP | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Aug 21, 2026 | KeyStone Co-Pack Manufacturing, LLC | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration… |
| Aug 14, 2026 | SDC Nutrition | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Jul 31, 2026 | Kimmie Candy Company, Inc | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration… |
| Jul 31, 2026 | Nutrixen Healthy LLC | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Jul 30, 2026 | All American Pharmaceuticals & Natural Foods Corp. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Jul 29, 2026 | Nutrikeo, LLC. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration… |
| Jul 14, 2026 | Enrinity Supplements, Inc. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration of the… |
| Jul 9, 2026 | Blue Mountain Labs LLC | United States | You did not verify that your finished batch of dietary supplement meets product specifications for limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement. |
| Jul 9, 2026 | Nouvelle Research, Inc. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement. |
| Jun 11, 2026 | Supplement Partners LLC | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration… |
| Jun 10, 2026 | LXR Biotech | United States | You did not verify that your finished batch of dietary supplement meets product specifications for limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement. |
| Jun 5, 2026 | Life And Health Alternatives Inc. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Jun 5, 2026 | Powerful Health Food Co., Ltd. | Japan | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| May 26, 2026 | Ace Packwell Pty., Ltd. | Australia | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration… |
| May 19, 2026 | CUSTOM FOODS PTY LTD | Australia | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| May 12, 2026 | Morlife Pty Ltd | Australia | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition and limits on contamination that may adulterate or that may lead to adulteration… |
| May 7, 2026 | Mytosynth Nutraceuticals, LLC | United States | You did not verify that your finished batch of dietary supplement meets product specifications for composition. |
| May 1, 2026 | KW Botanicals, Inc. | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity and strength. |
| Apr 27, 2026 | Enterprise Mac, LLC | United States | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
| Apr 17, 2026 | Essence Group Pty Ltd | Australia | You did not verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength and composition. |
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