21 CFR 211.58 citations
FDA investigators cited 21 CFR 211.58 320 times at 285 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 31, 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 | 17 |
| 2025 | 21 |
| 2024 | 19 |
| 2023 | 12 |
| 2022 | 14 |
| 2021 | 10 |
| 2020 | 8 |
| 2019 | 15 |
| 2018 | 26 |
| 2017 | 20 |
Recent citations
The latest inspections that cited this section. Facility names link to each facility's FDA record.
| Inspection ended | Facility | Country | Observation |
|---|---|---|---|
| Jul 31, 2026 | Aizant Drug Research Solutions Private Ltd. | India | Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. |
| Jun 12, 2026 | Inspec Solutions LLC | United States | Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair. |
| May 8, 2026 | Perrigo New York, Inc. | United States | Buildings used in the manufacturing of a drug product are not maintained in a good state of repair. |
| May 4, 2026 | Element Materials Technology Boston - Acton Inc. | United States | Buildings used in the processing of a drug product are not maintained in a good state of repair. |
| May 1, 2026 | GVS TM, Inc | United States | Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. |
| Apr 3, 2026 | Granules Pharmaceuticals Inc. | United States | Buildings used in the holding of a drug product are not maintained in a good state of repair. |
| Mar 10, 2026 | Lyne Laboratories, Inc. | United States | Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. |
| Feb 27, 2026 | Gasco Industrial Corp. | United States | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Feb 26, 2026 | CoreRX Inc. | United States | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Feb 10, 2026 | Kenvue Brands LLC | United States | Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. |
| Feb 5, 2026 | Fenwal International, Inc. | United States | Buildings used in the processing of a drug product are not maintained in a good state of repair. |
| Feb 3, 2026 | Iso-Tex Diagnostics, Inc. | United States | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Feb 3, 2026 | MEGHMANI LLP | India | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Nov 21, 2025 | Invahealth Inc. | United States | Buildings used in the manufacturing of a drug product are not maintained in a good state of repair. |
| Nov 19, 2025 | Vintage Chemical, Inc. | United States | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Nov 5, 2025 | Fresenius Kabi Compounding, LLC | United States | Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. |
| Oct 14, 2025 | Hill Dermaceuticals, Inc. | United States | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Sep 29, 2025 | Baxter Healthcare Corporation | United States | Buildings used in the manufacturing, processing and packing of a drug product are not maintained in a good state of repair. |
| Aug 27, 2025 | Beutlich Pharmaceuticals LLC | United States | Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. |
| Aug 8, 2025 | Fagron Compounding Services | United States | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Aug 6, 2025 | LGM Pharma Solutions, LLC. | United States | Buildings used in the processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Aug 5, 2025 | Winder Laboratories, LLC | United States | Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair. |
| Jul 31, 2025 | Telix IsoTherapeutics Group, Inc. | United States | Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. |
| Jul 25, 2025 | Avista Pharma Solutions, Inc. | United States | Buildings used in the processing of a drug product are not maintained in a good state of repair. |
| Jun 18, 2025 | Sheffield Pharmaceuticals, LLC | United States | Buildings used in the holding of a drug product are not maintained in a good state of repair. |
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