21 CFR 111.553 citations
FDA investigators cited 21 CFR 111.553 612 times at 538 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 18, 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 | 36 |
| 2024 | 27 |
| 2023 | 30 |
| 2022 | 33 |
| 2021 | 24 |
| 2020 | 21 |
| 2019 | 37 |
| 2018 | 43 |
| 2017 | 61 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Sep 18, 2026 | MuscleMart Inc. | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Sep 14, 2026 | Better Than Greens LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Aug 27, 2026 | Karuna Kava And Tea LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Aug 24, 2026 | Suyat Enterprises, LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jul 31, 2026 | Marlyn Nutraceuticals Inc | United States | You did not follow written procedures for the requirements to review and investigate a product complaint. |
| Jul 8, 2026 | Carefast Products Inc | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jul 8, 2026 | Nu-Scripts, Inc | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jun 18, 2026 | Sprinkk LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jun 16, 2026 | Nature's Rare LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jun 11, 2026 | Professional Business Associates Inc | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jun 11, 2026 | Trinity Natural Health & Pain Management,Inc. | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jun 5, 2026 | Healthy Land Inc. | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Jun 4, 2026 | LNS US LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| May 28, 2026 | Nuwati Herbals, Inc | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| May 21, 2026 | GMU SPORT LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| May 18, 2026 | Price Pharmaceuticals, LLC D.B.A. Just Move Supplements | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| May 15, 2026 | Hoa Da Canh Thien, Inc. | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| May 11, 2026 | Lifeaid Beverage Company, LLC | United States | You did not follow written procedures for the requirements to review and investigate a product complaint. |
| May 4, 2026 | FARMASI US LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Apr 20, 2026 | Shawkea USA | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Apr 9, 2026 | America Great Health | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Apr 2, 2026 | Inid Research Lab, LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Apr 2, 2026 | Wellnov Supplements LLC | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Mar 26, 2026 | B&A Frontier Trading Inc | United States | You did not establish written procedures for the requirements to review and investigate a product complaint. |
| Mar 26, 2026 | Dr. Rath International, Inc. | United States | You did not follow written procedures for the requirements to review and investigate a product complaint. |
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